NEUROMARK Registry Study

Not Applicable

Active, not recruiting

• Conditions: Chronic Rhinitis
• Interventions: Device: NEUROMARK System

• Registration Number: NCT05937308
• Lead Sponsor: Neurent Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-10
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NEUROMARK Treatment	NEUROMARK System	Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.

Primary Outcome Measures

Name	Time	Method
Efficacy - reflective Total Nasal Symptom Score (rTNSS)	36-month follow-up	Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Safety - incidence of device- and/or procedure-related serious adverse	36-month follow-up	Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

Trial Locations

Locations (7)

Alabama Nasal & Sinus Center; 🇺🇸 Birmingham, Alabama, United States

Sensa Health; 🇺🇸 Los Angeles, California, United States

Sacramento ENT; 🇺🇸 Roseville, California, United States

Florida ENT & Allergy; 🇺🇸 Brandon, Florida, United States

ENT & Allergy Texas; 🇺🇸 McKinney, Texas, United States

Ogden Clinic; 🇺🇸 Ogden, Utah, United States

Metropolitan ENT; 🇺🇸 Alexandria, Virginia, United States