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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2023-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NEUROMARK Randomized Controlled Trial

NCT06128200

Chronic Rhinitis

ACTIVE_NOT_RECRUITING NA

NEUROMARK Registry Study

NCT05937308

Chronic Rhinitis

ACTIVE_NOT_RECRUITING NA

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

NCT05324397

Chronic Rhinitis

COMPLETED NA

Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)

NCT05591989

Chronic Rhinitis

ACTIVE_NOT_RECRUITING NA

RhinAer Procedure for Treatment of Chronic Rhinitis Study

NCT04533438

Chronic Rhinitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, Double-blind, Sham Controlled Study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects, site investigator, site personnel, and sponsor will be blinded to which study arm they are randomized to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Subject in this arm will undergo treatment with the NEUROMARK device.

Group Type EXPERIMENTAL

NEUROMARK™ System

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Sham Device

Intervention Type DEVICE

A Sham device will be used in the nasal cavity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Sham Device

A Sham device will be used in the nasal cavity

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No