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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06128200
Other study ID # CIP-0010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT05648565 - Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis N/A
Completed NCT04769596 - Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis N/A