NEUROMARK Randomized Controlled Trial

Chronic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128200
• Other study ID #: CIP-0010
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Neurent Medical
• Contact: Annalise Sorensen
• Phone: 303-881-1757
• Email: annalise[@]neurentmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

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 NEUROMARK System
Sham ablation procedure using the NEUROMARK System

Locations

Country	Name	City	State
United States	Centers for Advanced ENT Care	Baltimore	Maryland
United States	Bethlehem ENT	Bethlehem	Pennsylvania
United States	ENT & Allergy Associates	Puyallup	Washington
United States	Richmond ENT	Richmond	Virginia
United States	Sacramento ENT	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurent Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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