NEUROMARK Registry Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: NEUROMARK System

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Alabama Nasal & Sinus Center
  • California
    • Los Angeles, California, United States, 90006
      • Sensa Health
    • Roseville, California, United States, 95661
      • Sacramento ENT
  • Florida
    • Brandon, Florida, United States, 33511
      • Florida ENT & Allergy
  • Texas
    • McKinney, Texas, United States, 75071
      • ENT & Allergy Texas
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden Clinic
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Metropolitan ENT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Neurent Medical
• Investigators: Study Director: Annalise Sorensen, Neurent Medical

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rhinitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis
• Other Study ID Numbers: CIP-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No