NCT05937308

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2023Sep 2027

Study Start

First participant enrolled

June 12, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

June 16, 2023

Last Update Submit

March 17, 2026

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (14)

  • 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

Study Arms (1)

NEUROMARK Treatment

OTHER

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

Device: NEUROMARK System

Interventions

NEUROMARK SystemDEVICE

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.

NEUROMARK Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject MUST:
  • Be ≥18 years of age.
  • Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
  • 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.
  • Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

You may not qualify if:

  • Subjects Must Not:
  • \. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alabama Nasal & Sinus Center

Birmingham, Alabama, 35242, United States

Location

Sensa Health

Los Angeles, California, 90006, United States

Location

Sacramento ENT

Roseville, California, 95661, United States

Location

Florida ENT & Allergy

Brandon, Florida, 33511, United States

Location

ENT & Allergy Texas

McKinney, Texas, 75071, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Metropolitan ENT

Alexandria, Virginia, 22310, United States

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Annalise Sorensen

    Neurent Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 10, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(7)