Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)

Study Overview
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Brief Summary
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The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.

Official Title
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Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.

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: Subjects 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. 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. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia. 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. Be willing and able to comply with all study elements, as indicated by written informed consent. Exclusion Criteria: Subjects 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 an active nasal or sinus infection. Have nasal mucosal erosion/ulceration. Have rhinitis symptoms that are due to seasonal allergies only. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized. Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity. Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months. Have been diagnosed with atrophic rhinitis. Have had previous head and/or neck irradiation. Have an allergy or intolerance to local anesthetic agents. Be pregnant. 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. Be participating in another clinical research study.

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, single-arm, multicenter clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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 | Safety, as assessed by the incidence of device- and/or procedure related serious adverse events (SAEs) | 24 months | 
| Efficacy | Efficacy, as assessed by the mean change from baseline in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score) at 6-month follow-up (FU) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from baseline in rTNSS total score (except 6-month FU) | The mean change from baseline in rTNSS total score (except 6-month FU) | 24 months | 
| The mean change from baseline in rTNSS subscores | The mean change from baseline in rTNSS subscores | 24 months | 
| The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score | The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score | 24 months | 
| The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score | The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score | 24 months | 
| Percent of subject satisfaction at follow-up | Percent of subject satisfaction at follow-up | 24 months | 
| Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score | Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score | 24 months | 

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