NEUROMARK Randomized Controlled Trial

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: NEUROMARK System; Device: Sham NEUROMARK System

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35204
      • ExcelENT
    • Opelika, Alabama, United States, 36801
      • East Alabama ENT
  • California
    • Los Angeles, California, United States, 90006
      • Sensa Health
    • Sacramento, California, United States, 95815
      • Sacramento ENT
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • ENT & Allergy Associates of Florida
    • Port Saint Lucie, Florida, United States, 34952
      • ENT & Allergy Associates of Florida
  • Indiana
    • Anderson, Indiana, United States, 46016
      • Ascension St. Vincent
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Advanced ENT & Allergy
    • Louisville, Kentucky, United States, 40205
      • Kentuckiana
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Centers for Advanced ENT Care
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Bethlehem ENT
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist ENT Specialists
    • McKinney, Texas, United States, 75708
      • The ENT & Allergy Centers of Texas
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Richmond ENT
  • Washington
    • Puyallup, Washington, United States, 98374-1145
      • ENT & Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participant Must:

1. Be ≥18 years of age.
2. Have been experiencing rhinitis symptoms for a minimum of 6 months.
3. 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.
4. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
5. Be willing and able to comply with all study elements, as indicated by written informed consent.

Primary Exclusion Criteria:

Participant Must Not:

1. 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.
2. Have had previous sinus or nasal surgery within 6 months of study enrollment.
3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
4. Have rhinitis symptoms that are due to seasonal allergies only.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Subjects in this arm will undergo treatment with the NEUROMARK device.	Device: NEUROMARK 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.
Sham Comparator: Sham; Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.	Device: Sham NEUROMARK System; Sham ablation procedure using the NEUROMARK System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rTNSS	Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days	90-days post procedure follow-up

Collaborators and Investigators

• Sponsor: Neurent Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis
• Other Study ID Numbers: CIP-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No