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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Rhinitis
• Intervention / Treatment: Device: NEUROMARK™ System; Device: Sham Device

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Alabama Allergy
  • California
    • Roseville, California, United States, 95661
      • Sacramento ENT
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado ENT
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • The Centers of Advanced ENT Care
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Specialty Physicians Associates
  • Texas
    • San Antonio, Texas, United States, 78258
      • Alamo ENT
  • Washington
    • Puyallup, Washington, United States, 98374
      • Ear, Nose, Throat, & Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subject in this arm will undergo treatment with the NEUROMARK device.	Device: 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.
Sham Comparator: 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.	Device: Sham Device; A Sham device will be used in the nasal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Serious Adverse Events (SAEs) directly attributable to the device	Safety	1 month

Collaborators and Investigators

• Sponsor: Neurent Medical
• Investigators: Study Director: Annalise Sorensen, Neurent Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: CLP-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No