NEUROMARK Registry Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05937308

Enrollment

150

Registered

2023-07-10

Start date

2023-06-12

Completion date

2027-09-01

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinitis

Keywords

Rhinitis

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.

Interventions

DEVICENEUROMARK 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety - incidence of device- and/or procedure-related serious adverse	3-month follow-up	Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Efficacy - reflective Total Nasal Symptom Score (rTNSS)	3-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

Countries

United States

Contacts

STUDY_DIRECTORAnnalise Sorensen

Neurent Medical

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026