NEUROMARK Randomized Controlled Trial

NCT06128200 | Completed FDA Device

• 1 other identifier: CIP-0010
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects in this arm will undergo treatment with the NEUROMARK device.

Device: NEUROMARK System

Sham

SHAM COMPARATOR

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

Interventions

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.

Active

Sham NEUROMARK System DEVICE

Sham ablation procedure using the NEUROMARK System

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurent Medical: lead

Study Sites (16)

ExcelENT

Homewood, Alabama, 35204, United States

Location

East Alabama ENT

Opelika, Alabama, 36801, United States

Location

Sensa Health

Los Angeles, California, 90006, United States

Location

Sacramento ENT

Sacramento, California, 95815, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

ENT & Allergy Associates of Florida

Boynton Beach, Florida, 33426, United States

Location

ENT & Allergy Associates of Florida

Port Saint Lucie, Florida, 34952, United States

Location

Ascension St. Vincent

Anderson, Indiana, 46016, United States

Location

Kentuckiana

Louisville, Kentucky, 40205, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40220, United States

Location

Centers for Advanced ENT Care

Baltimore, Maryland, 21204, United States

Location

Bethlehem ENT

Bethlehem, Pennsylvania, 18017, United States

Location

Houston Methodist ENT Specialists

Houston, Texas, 77030, United States

Location

The ENT & Allergy Centers of Texas

McKinney, Texas, 75708, United States

Location

Richmond ENT

Richmond, Virginia, 23235, United States

Location

ENT & Allergy Associates

Puyallup, Washington, 98374-1145, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study; participants will be blinded to the randomization assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: October 10, 2023
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)