Back to resultsNEUROMARK Registry Study
Primary Purpose
Chronic Rhinitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEUROMARK System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis focused on measuring Rhinitis
Eligibility Criteria
Inclusion Criteria: Subject MUST: Be ≥18 years of age. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use. Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent. Exclusion Criteria: Subjects Must Not: 1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
Sites / Locations
- Alabama Nasal & Sinus CenterRecruiting
- Sensa HealthRecruiting
- Sacramento ENTRecruiting
- Florida ENT & AllergyRecruiting
- ENT & Allergy TexasRecruiting
- Ogden ClinicRecruiting
- Metropolitan ENTRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NEUROMARK Treatment
Arm Description
Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.
Outcomes
Primary Outcome Measures
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Safety - incidence of device- and/or procedure-related serious adverse
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05937308
Brief Title
NEUROMARK Registry Study
Official Title
Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
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
The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects 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
Single Group Assignment
Model Description
A Prospective, Multicenter, Single-arm, Post-market Interventional Registry. Collect real-world evidence.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NEUROMARK Treatment
Arm Type
Other
Arm Description
Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.
Intervention Type
Device
Intervention Name(s)
NEUROMARK System
Intervention Description
The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
Primary Outcome Measure Information:
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
3-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
6-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
12-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
18-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
24-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
30-month follow-up
Title
Safety - incidence of device- and/or procedure-related serious adverse
Description
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
Time Frame
36-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
3-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
6-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
12-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
18-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
24-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
30-month follow-up
Title
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Description
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Time Frame
36-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject MUST:
Be ≥18 years of age.
Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening.
Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.
Exclusion Criteria:
Subjects Must Not:
1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annalise Sorensen
Phone
303-881-1757
Email
annalise@neurentmedical.com
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 Nasal & Sinus Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Spates
Phone
205-419-7738
Email
brittany.spates@wrightclinical.com
First Name & Middle Initial & Last Name & Degree
Rachel Norris
Phone
205-419-7738
Email
rachel.norris@wrightclinical.com
First Name & Middle Initial & Last Name & Degree
Michael Sillers, MD
First Name & Middle Initial & Last Name & Degree
Kristopher Lay, MD
Facility Name
Sensa Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Yang
Phone
213-267-2256
Email
jee@sensahealth.org
First Name & Middle Initial & Last Name & Degree
Kevin Choi
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rose Khalatyan
Phone
916-374-6730
Email
rkhalatyan@davinciresearch.net
First Name & Middle Initial & Last Name & Degree
Randall Ow, MD
Facility Name
Florida ENT & Allergy
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Betschner
Phone
813-879-8045
Email
jabetschner@entaaf.com
First Name & Middle Initial & Last Name & Degree
Scott Powell
Facility Name
ENT & Allergy Texas
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Morisanto
Phone
972-984-1050
Email
vmorisato@enttx.com
First Name & Middle Initial & Last Name & Degree
Richard Thrasher
First Name & Middle Initial & Last Name & Degree
Shane Pahlavan
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Erickson
Phone
801-475-3072
Email
Ashley.Erickson@ogdenclinic.com
First Name & Middle Initial & Last Name & Degree
Brittany Davis
Phone
801-475-3086
Email
Brittany.Davis@ogdenclinic.com
First Name & Middle Initial & Last Name & Degree
Nadim Bikhazi, MD
First Name & Middle Initial & Last Name & Degree
Doug Anderson, MD
Facility Name
Metropolitan ENT
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendall Jordan
Phone
703-313-7700
Email
kjordan@lmgdoctors.com
First Name & Middle Initial & Last Name & Degree
Adriana Mendez
Phone
703-313-7700
Email
amendez@lmgdoctors.com
First Name & Middle Initial & Last Name & Degree
Ravi Swamy, MD
First Name & Middle Initial & Last Name & Degree
Iyad Saidi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NEUROMARK Registry Study
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