NEUROMARK Randomized Controlled Trial

Study Overview
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Brief Summary
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The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.

Official Title
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Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: NEUROMARK System
* Device: Sham NEUROMARK System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant Must: Be ≥18 years of age. Have been experiencing rhinitis symptoms for a minimum of 6 months. 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. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia. Be willing and able to comply with all study elements, as indicated by written informed consent. Primary Exclusion Criteria: Participant Must Not: 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. Have had previous sinus or nasal surgery within 6 months of study enrollment. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis. Have rhinitis symptoms that are due to seasonal allergies only.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Subjects in this arm will undergo treatment with the NEUROMARK device. | Device: NEUROMARK System<br>* 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.<br>|
| Sham Comparator: Sham<br>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<br>* Sham ablation procedure using the NEUROMARK System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rTNSS | Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days | 90-days post procedure follow-up |