NEUROMARK Randomized Controlled Trial
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
- 132 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
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:
Participant 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. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
5. Be willing and able to comply with all study elements, as indicated by written informed consent.
Primary Exclusion Criteria:
Participant 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 rhinitis symptoms that are due to seasonal allergies only.
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
- Random assignment
- Masking
- Single masked
Active
Subjects in this arm will undergo treatment with the NEUROMARK device.
Device: NEUROMARK System
Sham
Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.
Device: Sham 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.
Sham NEUROMARK System DEVICE
Sham ablation procedure using the NEUROMARK System
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
rTNSS Responder Rate
Time frame: 90-days post procedure follow-up
Percentage of responders (participants with a 30% or greater reduction in total rTNSS relative to baseline). 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). 30% or greater reduction in score from baseline.
Secondary measures
rTNSS Total Score
Time frame: 90-Days post procedure follow up
Mean change from baseline in the rTNSS score. 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).
NOSE Total Score
Time frame: 90 days post procedure follow up
Mean change from baseline in the NOSE score. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. Max Score: 100; Min Score: 0. Lower values indicate a better outcome. Each question is added for a raw score (ranging from 0 to 20) and then the raw score is multiplied by 5 yielding a final total (ranging from 0 to 100).
Mini-RQLQ Total Score
Time frame: 90 days post procedure follow up
Mean change from baseline in the Mini-RQLQ score. 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.
Number of Participants With Device- and/or Procedure-Related Serious Adverse Events
Time frame: 90 days post procedure follow up
Number of participants with Incidences of device- and/or procedure-related serious adverse events (SAEs)
Other measures
rTNSS Congestion
Time frame: 90 Days post procedure follow up
Mean change in rTNSS congestion subscore. 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
Time frame: 90 Days post procedure follow up
Mean change in rTNSS rhinorrhea subscore. 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 Sneezing
Time frame: 90 Days post procedure follow up
Mean change in rTNSS sneezing subscore. 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 Itching
Time frame: 90 Days post procedure follow up
Mean change in rTNSS itching subscore. 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.
Postnasal Drip
Time frame: 90 days post procedure follow up
Mean change from baseline in postnasal drip score. Postnasal drip is a single question evaluating severity of symptom in the past 12 hours on a scale from 0 to 3. Max score: 3 Min Score: 0. Lower values indicate a better outcome.
Cough
Time frame: 90 days post procedure follow up
Mean change from baseline in cough score. Cough assessment is a single question rating severity of symptom in the past 12 hours on a scale from 0 to 3. Max score: 3 Min Score: 0. Lower scores indicate a better outcome.
NOSE Responder Rate
Time frame: 90 days post procedure follow up
The percent of NOSE responders (at least one NOSE class improvement or reduction of greater than or equal to 20% compared to baseline). The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. Max Score: 100; Min Score: 0. Lower values indicate a better outcome. Each question is added for a raw score (ranging from 0 to 20) and then the raw score is multiplied by 5 yielding a final total (ranging from 0 to 100). The percent of NOSE responders with at least one NOSE class improvement or reduction of greater than or equal to 20%.
NOSE Nasal Congestion
Time frame: 90 Day Post Procedure Follow Up
Mean change from baseline in NOSE nasal congestion subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Nasal Congestion subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.
NOSE Nasal Blockage/Obstruction
Time frame: 90 Day Post Procedure Follow Up
Mean change from baseline in NOSE Nasal blockage/obstruction subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Nasal Blockage/obstruction subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.
NOSE Trouble Breathing Through Nose
Time frame: 90 Day Post Procedure Follow Up
Mean change from baseline in NOSE Trouble breathing through nose subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Trouble breathing through nose subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.
NOSE Trouble Sleeping
Time frame: 90 Days Post Procedure Follow Up
Mean change from baseline in NOSE Trouble sleeping subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Trouble sleeping subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.
NOSE Difficulty Getting Air Through Nose During Exercise
Time frame: 90 Day Post Procedure Follow Up
Mean change from baseline in NOSE Difficulty getting air through nose during exercise subscore. The NOSE (Nasal Obstruction Symptom Evaluation) scale is a 5-question patient-reported survey used to measure the severity of nasal obstruction and its impact on quality of life. The NOSE Difficulty getting air through nose during exercise subscore is a single question rated 0 to 4. Max score: 4 Min score: 0. Lower values indicate a better outcome.
Mini-RQLQ MCID
Time frame: 90 days post procedure follow up
The percent of participants achieving the MCID in Mini-RQLQ score (greater than or equal to .4 point improvement compared to baseline). 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.
Mini-RQLQ Activities (Including Sleep)
Time frame: 90 Day Post Procedure Follow Up
Mean change from baseline in Mini-RQLQ activities domain score. 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. The Activities (including sleep) domain score is calculated by averaging responses from 3 questions regarding regular activities rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.
Mini-RQLQ Practical Problems
Time frame: 90 day post procedure follow up
Mean change from baseline in Mini-RQLQ practical problems domain score. 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. The Practical Problems domain score is calculated by averaging responses from 2 questions regarding practical problems rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.
Mini-RQLQ Nose Symptoms
Time frame: 90 days post procedure follow up
Mean change from baseline in Mini-RQLQ nose symptoms domain score. 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. The Nose symptoms domain score is calculated by averaging responses from 3 questions regarding nose symptoms rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.
Mini-RQLQ Eye Symptoms
Time frame: 90 day post procedure follow up
Mean change from baseline in Mini-RQLQ eye symptoms domain score. 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. The Eye Symptoms domain score is calculated by averaging responses from 3 questions regarding eye symptoms rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.
Mini-RQLQ Other Symptoms
Time frame: 90 days post procedure follow up
Mean change from baseline in Mini-RQLQ other symptoms domain score. 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. The Other Symptoms domain score is calculated by averaging responses from 3 questions rated from 0-6. Max Score: 6 Min Score: 0. Lower values indicate a better outcome.
PHQ-9
Time frame: 90 days post procedure follow up
Mean change from baseline in PHQ-9 score. The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to evaluate the presence and severity of depressive symptoms over the past two weeks. Max Score: 81. Min Score: 0. Lower values indicate a better outcome. Responses to each question are added to create a total score.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (16)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
16 locations
ExcelENTHomewood, Alabama, United StatesStatus unknown
East Alabama ENTOpelika, Alabama, United StatesStatus unknown
Sensa HealthLos Angeles, California, United StatesStatus unknown
Sacramento ENTSacramento, California, United StatesStatus unknown
Breathe Clear InstituteTorrance, California, United StatesStatus unknown
ENT & Allergy Associates of FloridaBoynton Beach, Florida, United StatesStatus unknown
ENT & Allergy Associates of FloridaPort Saint Lucie, Florida, United StatesStatus unknown
Ascension St. VincentAnderson, Indiana, United StatesStatus unknown
KentuckianaLouisville, Kentucky, United StatesStatus unknown
Advanced ENT & AllergyLouisville, Kentucky, United StatesStatus unknown
Centers for Advanced ENT CareBaltimore, Maryland, United StatesStatus unknown
Bethlehem ENTBethlehem, Pennsylvania, United StatesStatus unknown
Houston Methodist ENT SpecialistsHouston, Texas, United StatesStatus unknown
The ENT & Allergy Centers of TexasMcKinney, Texas, United StatesStatus unknown
Richmond ENTRichmond, Virginia, United StatesStatus unknown
ENT & Allergy AssociatesPuyallup, Washington, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- Neurent Medical
- Study start
- Oct 10, 2023 Actual
- Primary completion
- Nov 26, 2025 Actual
- Study completion
- Nov 26, 2025 Actual
- First posted
- Nov 13, 2023 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
Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
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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