NEUROMARK Registry Study

Chronic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937308
• Other study ID #: CIP-0008
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: September 2027

Study information

• Verified date: October 2023
• Source: Neurent Medical
• Contact: Annalise Sorensen
• Phone: 303-881-1757
• Email: annalise[@]neurentmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subject MUST:

1. Be =18 years of age.

2. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.

3. 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.

4. 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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• NEUROMARK System
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.

Locations

Country	Name	City	State
United States	Metropolitan ENT	Alexandria	Virginia
United States	Alabama Nasal & Sinus Center	Birmingham	Alabama
United States	Florida ENT & Allergy	Brandon	Florida
United States	Sensa Health	Los Angeles	California
United States	ENT & Allergy Texas	McKinney	Texas
United States	Ogden Clinic	Ogden	Utah
United States	Sacramento ENT	Roseville	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurent Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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