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

Chronic Rhinitis Clinical Trial

— MERIDIEN  

Official title:

Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769596
• Other study ID #: CLP-0005
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: May 10, 2023

Study information

• Verified date: July 2023
• Source: Neurent Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• NEUROMARK™ System
The NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis.
• Sham Device
A Sham device will be used in the nasal cavity

Locations

Country	Name	City	State
United States	Specialty Physicians Associates	Bethlehem	Pennsylvania
United States	Alabama Allergy	Birmingham	Alabama
United States	Colorado ENT	Colorado Springs	Colorado
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Ear, Nose, Throat, & Allergy Associates	Puyallup	Washington
United States	Sacramento ENT	Roseville	California
United States	Alamo ENT	San Antonio	Texas
United States	The Centers of Advanced ENT Care	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Neurent Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Serious Adverse Events (SAEs) directly attributable to the device	Safety	1 month