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

Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis - A Prospective, Single-arm, Multicenter Clinical Study

NCT05324397•Neurent Medical

View on ClinicalTrials.gov

Summary

The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects 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.
•Confirmation of moderate to severe symptoms of rhinorrhea. (VAS NSS score for runny nose ≥ 5.0 and rTNSS score for runny nose ≥ 2).
•Confirmation of mild to severe symptoms of nasal congestion. (VAS NSS score ≥ 2.5 for stuffy nose (congestion) and rTNSS score of ≥ 1).
•Confirmation that the total combined VAS NSS score is ≥ 10 for nasal congestion and runny nose.
•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.).
+2 more criteria

Exclusion Criteria

•Subject has clinically significant anatomic obstruction that limits access to the posterior nose as determined by the Study Investigator such as severe septal deviation, prior surgical considerations, cleft palate, nasal polyps, or sino-nasal tumor.
•Subject has an active nasal or sinus infection at the time of treatment.
•Subject has a diagnosis of Atrophic Rhinitis.
•Subject has a Lund-Mackay score \>3 during the screening phase, an active history of chronic sinusitis (within the last year).
•Subject has a septal perforation or nasal mucosal erosion/ulceration.
•Subject experiences numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sino-nasal anatomy.
•Subject has had prior sinus or nasal surgery that may prevent access or proper placement of the NEUROMARK™ System.
•Subject has had prior head or neck irradiation (head/neck cancer therapy).
•Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
•Subject is taking anticoagulant medication or 325 mg aspirin that cannot be discontinued before the procedure and for the length of the study.
+13 more criteria

Locations (4)

Alabama Nasal and Sinus Center

Birmingham, Alabama, United States

Centers for Advanced ENT Care

Baltimore, Maryland, United States

Specialty Physician Associates

Bethlehem, Pennsylvania, United States

ENT & Allergy Associcates

Puyallup, Washington, United States

Key Dates

Start Date

March 14, 2022

Primary Completion Date

October 4, 2023

Completion Date

October 4, 2023

Last Updated

November 13, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Rhinitis

Interventions

NEUROMARK System

DEVICE

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

NCT04769596

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: November 13, 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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