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Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis | Clinical Trials | Clareo Health

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

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

NCT04769596•Neurent Medical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (8)

Alabama Allergy

Birmingham, Alabama, United States

Sacramento ENT

Roseville, California, United States

Colorado ENT

Colorado Springs, Colorado, United States

Tandem Clinical Research

Marrero, Louisiana, United States

The Centers of Advanced ENT Care

Towson, Maryland, United States

Specialty Physicians Associates

Bethlehem, Pennsylvania, United States

Alamo ENT

San Antonio, Texas, United States

Ear, Nose, Throat, & Allergy Associates

Puyallup, Washington, United States

Key Dates

Start Date

February 23, 2021

Primary Completion Date

May 10, 2023

Completion Date

May 10, 2023

Last Updated

July 19, 2023

Enrollment

143

ACTUAL participants

Conditions

Chronic Rhinitis

Interventions

NEUROMARK™ System

DEVICE

Sham Device

DEVICE

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

NCT05324397

Chronic Rhinitis

View study

TERMINATEDPHASE4

Surgical Reduction of the Inferior Turbinates for Nasal Obstruction

NCT00737906

Chronic RhinitisInflammation of the Nasal Mucosa+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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