Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)
Chronic Rhinitis
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 80 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Total rTNSS Score 6M
Time frame: 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
Time frame: 24-Month Follow Up
Number of participants who experienced a device- and/or procedure-related serious adverse event during the course of the study.
Secondary measures
Total rTNSS Score 1M
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (10)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
10 locations
Alabama Nasal and Sinus Center (Alabama Allergy)Birmingham, Alabama, United StatesStatus unknown
Sacramento ENTCalifornia City, California, United StatesStatus unknown
United Medical DoctorsTemecula, California, United StatesStatus unknown
Colorado ENTColorado Springs, Colorado, United StatesStatus unknown
New Orleans Sinus CenterMarrero, Louisiana, United StatesStatus unknown
Centers for Advanced ENT Care (CAdENT)Baltimore, Maryland, United StatesStatus unknown
Rontal ClinicsRoyal Oak, Michigan, United StatesStatus unknown
Specialty Physician AssociatesBethlehem, Pennsylvania, United StatesStatus unknown
Richmond ENTRichmond, Virginia, United StatesStatus unknown
Ear Nose Throat & Allergy AssociatesSeattle, Washington, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Neurent Medical
- Study start
- Sep 26, 2022 Actual
- Primary completion
- Aug 5, 2025 Actual
- Study completion
- Aug 5, 2025 Actual
- First posted
- Oct 24, 2022 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026