NCT04769596

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

February 15, 2021

Last Update Submit

July 18, 2023

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (1)

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

    Safety

    1 month

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: NEUROMARK™ System

Sham

SHAM COMPARATOR

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

Interventions

NEUROMARK™ SystemDEVICE

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.

Treatment
Sham DeviceDEVICE

A Sham device will be used in the nasal cavity

Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Alabama Allergy

Birmingham, Alabama, 35242, United States

Location

Sacramento ENT

Roseville, California, 95661, United States

Location

Colorado ENT

Colorado Springs, Colorado, 80923, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

The Centers of Advanced ENT Care

Towson, Maryland, 21204, United States

Location

Specialty Physicians Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Alamo ENT

San Antonio, Texas, 78258, United States

Location

Ear, Nose, Throat, & Allergy Associates

Puyallup, Washington, 98374, United States

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Annalise Sorensen

    Neurent Medical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects, site investigator, site personnel, and sponsor will be blinded to which study arm they are randomized to.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, Double-blind, Sham Controlled Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 24, 2021

Study Start

February 23, 2021

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(8)