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

Neurent Medical

Status

Completed

Conditions

Chronic Rhinitis

Treatments

Device: Sham Device

Device: NEUROMARK™ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04769596

CLP-0005

Details and patient eligibility

About

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

Full 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.

Enrollment

143 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.