NEUROMARK Registry Study

Study Overview
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Brief Summary
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The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.

Official Title
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Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis

Conditions
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Chronic Rhinitis

Intervention / Treatment
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* Device: NEUROMARK System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject MUST: Be ≥18 years of age. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use. Have moderate to severe symptoms of running 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 screening. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent. Exclusion Criteria: Subjects Must Not: 1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.

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
Intervention Model: Single Group Assignment
Interventional Model Description: A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NEUROMARK Treatment<br>Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System. | 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 3-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 6-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 12-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 18-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 24-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 30-month follow-up | 
| Safety - incidence of device- and/or procedure-related serious adverse | Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs). | 36-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 3-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 6-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 12-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 18-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 24-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 30-month follow-up | 
| Efficacy - reflective Total Nasal Symptom Score (rTNSS) | Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up | 36-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinitis