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OpenTrials
Completed

NCT Number: NCT06128200

NEUROMARK Randomized Controlled Trial

The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.

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Key information

Conditions

Chronic Rhinitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ExcelENT, Homewood, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participant Must:

  • Be ≥18 years of age.
  • Have been experiencing rhinitis symptoms for a minimum of 6 months.
  • Have moderate to severe symptoms of runny 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 baseline.
  • Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
  • Be willing and able to comply with all study elements, as indicated by written informed consent.

Primary Exclusion Criteria:

Participant Must Not:

  • Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
  • Have had previous sinus or nasal surgery within 6 months of study enrollment.
  • Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
  • Have rhinitis symptoms that are due to seasonal allergies only.

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.

Sham NEUROMARK System

Device

Sham ablation procedure using the NEUROMARK System

Primary outcomes

  1. rTNSS

    Time frame: 90-days post procedure follow-up

    Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days

Sponsors and collaborators

Lead sponsor

Neurent Medical

Industry

Registry information

Official study title

Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Mar 19, 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.

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