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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Rhinitis

In brief

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

Key facts

Study ID

NCT04769596

Run by

Neurent Medical

People needed

143

Starts

2021-02-23

Expected to finish

2023-05-10

Last updated by the study team

2023-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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