Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis

Not Applicable

Completed

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

• Registration Number: NCT04769596
• Lead Sponsor: Neurent Medical

Brief Summary

A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis

Detailed Description

The MERIDIEN Study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the NEUROMARK™ System in patients with Chronic Rhinitis.

Study Timeline

• Study First Submitted: 2021-02-15
• Study Start: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-24
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• Subject provides written informed consent, including authorization to release health information.
• Subject is 18 years of age or older at the time of consent.
• Subject has provided a negative pregnancy test (if Subject is a woman of childbearing potential (WOCBP).
• Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
• Subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year.
• Subject tests negative for active COVID-19 at the start of study screening and continues to be free from COVID-19 symptoms until the time of enrollment/treatment.
• Subject understands and agrees to follow local COVID-19 restrictions (social distancing, face mask, etc.)

Exclusion Criteria

• Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
• Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
• Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
• Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
• Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results
• Patient presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere significantly with the Subject's participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham	Sham Device	Subjects in this arm will undergo the procedure with a Sham device. At 3 months post treatment these subjects will cross over to Arm 1.
Treatment	NEUROMARK™ System	Subject in this arm will undergo treatment with the NEUROMARK device.

Primary Outcome Measures

Name	Time	Method
Frequency of Serious Adverse Events (SAEs) directly attributable to the device	1 month	Safety

Trial Locations

Locations (8)

Colorado ENT; 🇺🇸 Colorado Springs, Colorado, United States

Alabama Allergy; 🇺🇸 Birmingham, Alabama, United States

Alamo ENT; 🇺🇸 San Antonio, Texas, United States

Ear, Nose, Throat, & Allergy Associates; 🇺🇸 Puyallup, Washington, United States

Sacramento ENT; 🇺🇸 Roseville, California, United States

The Centers of Advanced ENT Care; 🇺🇸 Towson, Maryland, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Specialty Physicians Associates; 🇺🇸 Bethlehem, Pennsylvania, United States