Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05937308

NEUROMARK Registry Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Nasal & Sinus Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

NEUROMARK System

Device

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.

Primary outcomes

  1. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 3-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  2. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 6-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  3. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 12-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  4. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 18-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  5. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 24-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  6. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 30-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  7. Safety - incidence of device- and/or procedure-related serious adverse

    Time frame: 36-month follow-up

    Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).

  8. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 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

  9. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 6-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

  10. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 12-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

  11. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 18-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

  12. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 24-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

  13. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 30-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

  14. Efficacy - reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Neurent Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.