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

Primary Purpose

Chronic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEUROMARK™ System
Sham Device
Sponsored by
Neurent Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinitis focused on measuring Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • 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.

Sites / Locations

  • Alabama Allergy
  • Sacramento ENT
  • Colorado ENT
  • Tandem Clinical Research
  • The Centers of Advanced ENT Care
  • Specialty Physicians Associates
  • Alamo ENT
  • Ear, Nose, Throat, & Allergy Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Frequency of Serious Adverse Events (SAEs) directly attributable to the device
Safety

Secondary Outcome Measures

Full Information

First Posted
February 15, 2021
Last Updated
July 18, 2023
Sponsor
Neurent Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04769596
Brief Title
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
Acronym
MERIDIEN
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurent Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
Keywords
Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, Double-blind, Sham Controlled Study
Masking
Participant
Masking Description
Subjects, site investigator, site personnel, and sponsor will be blinded to which study arm they are randomized to.
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subject in this arm will undergo treatment with the NEUROMARK device.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NEUROMARK™ System
Intervention Description
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
Intervention Name(s)
Sham Device
Intervention Description
A Sham device will be used in the nasal cavity
Primary Outcome Measure Information:
Title
Frequency of Serious Adverse Events (SAEs) directly attributable to the device
Description
Safety
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annalise Sorensen
Organizational Affiliation
Neurent Medical
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Allergy
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Colorado ENT
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
The Centers of Advanced ENT Care
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Specialty Physicians Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Alamo ENT
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Ear, Nose, Throat, & Allergy Associates
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98374
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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