NEUROMARK Randomized Controlled Trial

Not Applicable

Active, not recruiting

• Conditions: Chronic Rhinitis
• Interventions: Device: NEUROMARK System; Device: Sham NEUROMARK System

• Registration Number: NCT06128200
• Lead Sponsor: Neurent Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Study Completion: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	NEUROMARK System	Subjects in this arm will undergo treatment with the NEUROMARK device.
Sham	Sham NEUROMARK System	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.

Primary Outcome Measures

Name	Time	Method
rTNSS	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

Trial Locations

Locations (15)

ExcelENT; 🇺🇸 Homewood, Alabama, United States

East Alabama ENT; 🇺🇸 Opelika, Alabama, United States

Sensa Health; 🇺🇸 Los Angeles, California, United States

Breathe Clear Institute; 🇺🇸 Torrance, California, United States

ENT & Allergy Associates of Florida; 🇺🇸 Port Saint Lucie, Florida, United States

Ascension St. Vincent; 🇺🇸 Anderson, Indiana, United States

Kentuckiana; 🇺🇸 Louisville, Kentucky, United States

Advanced ENT & Allergy; 🇺🇸 Louisville, Kentucky, United States

Houston Methodist ENT Specialists; 🇺🇸 Houston, Texas, United States

The ENT & Allergy Centers of Texas; 🇺🇸 McKinney, Texas, United States

Sacramento ENT; 🇺🇸 Sacramento, California, United States

Centers for Advanced ENT Care; 🇺🇸 Baltimore, Maryland, United States

Bethlehem ENT; 🇺🇸 Bethlehem, Pennsylvania, United States

Richmond ENT; 🇺🇸 Richmond, Virginia, United States

ENT & Allergy Associates; 🇺🇸 Puyallup, Washington, United States