Clinical trial NCT04769596: Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
Official title: Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Keywords: Rhinitis
Lead sponsor: Neurent Medical
Sponsor class: INDUSTRY
First posted: 2021-02-24
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-blind, Sham Controlled Study
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Frequency of Serious Adverse Events (SAEs) directly attributable to the device
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy
state: Alabama
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT
state: Colorado
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Towson
country: United States
facility: The Centers of Advanced ENT Care
state: Maryland
city: Bethlehem
country: United States
facility: Specialty Physicians Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo ENT
state: Texas
city: Puyallup
country: United States
facility: Ear, Nose, Throat, & Allergy Associates
state: Washington
Study officials:
affiliation: Neurent Medical
name: Annalise Sorensen
role: STUDY_DIRECTOR
References: