Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)
Chronic Rhinitis
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 80 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
Subjects MUST:
1. Be ≥18 years of age.
2. Have been experiencing rhinitis symptoms for a minimum of 6 months.
3. Have moderate to severe symptoms of runny nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1,2, or 3), and a minimum total score of 5 (out of 12) at baseline.
4. Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E \[IgE test\]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit.
5. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
6. Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment.
7. Be willing and able to comply with all study elements, as indicated by written informed consent.
Exclusion Criteria:
Subjects MUST NOT:
1. Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
2. Have had previous sinus or nasal surgery within 6 months of study enrollment.
3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
4. Have an active nasal or sinus infection.
5. Have nasal mucosal erosion/ulceration.
6. Have rhinitis symptoms that are due to seasonal allergies only.
7. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
8. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.
9. Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure.
10. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
11. Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
12. Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months.
13. Have been diagnosed with atrophic rhinitis.
14. Have had previous head and/or neck irradiation.
15. Have an allergy or intolerance to local anesthetic agents.
16. Be pregnant.
17. Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the subject at risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
18. Be participating in another clinical research study.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Treatment
Subjects will undergo treatment with the NEUROMARK System
Device: NEUROMARK System
NEUROMARK System DEVICE
The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Total rTNSS Score 6M
Plazo: 6-Month Follow Up
Change in total rTNSS score from baseline at 6-Month Follow up. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Device- and/or Procedure-related SAEs
Plazo: 24-Month Follow Up
Number of participants who experienced a device- and/or procedure-related serious adverse event during the course of the study.
Medidas secundarias
Total rTNSS Score 1M
Plazo: 1-Month Follow Up
Change in total rTNSS score from baseline at the 1-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 3M
Plazo: 3-Month Follow Up
Change in total rTNSS score from baseline at the 3-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 9M
Plazo: 9-Month Follow Up
Change in total rTNSS score from baseline at 9-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 12M
Plazo: 12-Month Follow Up
Change in total rTNSS score from baseline at the 12-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 15M
Plazo: 15-Month Follow Up
Change in total rTNSS score from baseline at 15-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 18M
Plazo: 18-Month Follow Up
Change in total rTNSS score from baseline at 18-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 21M
Plazo: 21-Month Follow Up
Change in total rTNSS score from baseline at 21-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
Total rTNSS Score 24M
Plazo: 24-Month Follow Up
Change in rTNSS score from baseline at the final 24-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. Max score: 12 Min score: 0. Lower values indicate a better outcome. 4 subscales (0-3 score) add together to create total score (out of 12).
rTNSS Congestion Score 1M
Plazo: 1-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 1-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 1M
Plazo: 1-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 1-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 1M
Plazo: 1-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 1-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 1M
Plazo: 1-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 1-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 3M
Plazo: 3-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 3-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 3M
Plazo: 3-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 3-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 3M
Plazo: 3-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 3-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 3M
Plazo: 3-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 3-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 6M
Plazo: 6-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 6-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 6M
Plazo: 6-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 6-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 6M
Plazo: 6-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 6-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 6M
Plazo: 6-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 6-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 9M
Plazo: 9-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 9-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 9M
Plazo: 9-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 9-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 9M
Plazo: 9-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 9-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 9M
Plazo: 9-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 9-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 12M
Plazo: 12-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 12-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 12M
Plazo: 12-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 12-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 12M
Plazo: 12-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 12-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 12M
Plazo: 12-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 12-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 15M
Plazo: 15-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 15-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 15M
Plazo: 15-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 15-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 15M
Plazo: 15-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 15-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 15M
Plazo: 15-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 15-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 18M
Plazo: 18-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 18-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 18M
Plazo: 18-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 18-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 18M
Plazo: 18-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 18-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 18M
Plazo: 18-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 18-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 21M
Plazo: 21-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 21-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 21M
Plazo: 21-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 21-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 21M
Plazo: 21-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 21-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 21M
Plazo: 21-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 21-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Congestion Score 24M
Plazo: 24-Month Follow Up
Change in rTNSS congestion subscore from baseline at the 24-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Congestion. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Rhinorrhea Score 24M
Plazo: 24-Month Follow Up
Change in rTNSS rhinorrhea subscore from baseline at the 24-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Rhinorrhea. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Nasal Itching Score 24M
Plazo: 24-Month Follow Up
Change in rTNSS nasal itching subscore from baseline at the 24-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Nasal Itching. Max score: 3 Min score: 0. Lower values indicate a better outcome.
rTNSS Sneezing Score 24M
Plazo: 24-Month Follow Up
Change in rTNSS sneezing subscore from baseline at the 24-month follow up visit. The Reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome questionnaire used to evaluate the severity of nasal symptoms over a recent period of 12 hours. This subscore evaluates Sneezing. Max score: 3 Min score: 0. Lower values indicate a better outcome.
Total Mini-RQLQ Score 3M
Plazo: 3-Month Follow Up
Change in total mini-RQLQ score from baseline at the 3-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Total Mini-RQLQ Score 6M
Plazo: 6-Month Follow Up
Change in total mini-RQLQ score from baseline at the 6-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Total Mini-RQLQ Score 12M
Plazo: 12-Month Follow Up
Change in total mini-RQLQ score from baseline at the 12-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Total Mini-RQLQ Score 18M
Plazo: 18-Month Follow Up
Change in total mini-RQLQ score from baseline at the 18-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Total Mini-RQLQ Score 21M
Plazo: 21-Month Follow Up
Change in total mini-RQLQ score from baseline at the 21-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Total Mini-RQLQ Score 24M
Plazo: 24-Month Follow Up
Change in total mini-RQLQ score from baseline at the 24-month follow up visit. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) is an abbreviated, 14-item self-administered health status questionnaire designed to measure functional impairments in adults with seasonal or perennial rhinoconjunctivitis. Max Score: 6 Min Score: 0. Lower values indicate a better outcome. Each question is scored 0-6 and the 14 question responses are averaged to create a total score.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (10)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
10 centros
Alabama Nasal and Sinus Center (Alabama Allergy)Birmingham, Alabama, United StatesEstado desconocido
Sacramento ENTCalifornia City, California, United StatesEstado desconocido
United Medical DoctorsTemecula, California, United StatesEstado desconocido
Colorado ENTColorado Springs, Colorado, United StatesEstado desconocido
New Orleans Sinus CenterMarrero, Louisiana, United StatesEstado desconocido
Centers for Advanced ENT Care (CAdENT)Baltimore, Maryland, United StatesEstado desconocido
Rontal ClinicsRoyal Oak, Michigan, United StatesEstado desconocido
Specialty Physician AssociatesBethlehem, Pennsylvania, United StatesEstado desconocido
Richmond ENTRichmond, Virginia, United StatesEstado desconocido
Ear Nose Throat & Allergy AssociatesSeattle, Washington, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Neurent Medical
- Inicio del estudio
- 26 sept 2022 Real
- Finalización primaria
- 5 ago 2025 Real
- Finalización del estudio
- 5 ago 2025 Real
- Primera publicación
- 24 oct 2022 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026