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Neurostimulation Device
NEUROMARK System for Chronic Rhinitis
N/A
Waitlist Available
Research Sponsored by Neurent Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have been experiencing rhinitis symptoms for a minimum of 6 months
Be ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests a device to help people with chronic rhinitis. It checks its safety & effectiveness.
Who is the study for?
This trial is for adults over 18 with chronic rhinitis, experiencing symptoms like a runny nose and nasal congestion for at least 6 months. They must have had an allergy test within the last 5 years or be willing to take one. Participants should not have active COVID-19, recent nasal surgery, plans for ENT procedures soon, or be on certain blood thinners. Pregnant individuals and those with specific medical conditions that could interfere with the study are excluded.Check my eligibility
What is being tested?
The PARAGON study is testing the NEUROMARK System's safety and effectiveness in treating chronic rhinitis symptoms. This single-arm trial involves multiple centers where participants will undergo treatment under local anesthesia to see if their condition improves.See study design
What are the potential side effects?
While specific side effects of the NEUROMARK System aren't listed here, potential risks may include discomfort from local anesthesia, bleeding due to the procedure, infection risk post-treatment, and possible reactions related to underlying health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had symptoms of rhinitis for at least 6 months.
Select...
I am 18 years old or older.
Select...
I tested negative for COVID-19 and have no symptoms.
Select...
I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy
Safety
Secondary outcome measures
Percent of subject satisfaction at follow-up
The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score
The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Subjects will undergo treatment with the NEUROMARK System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NEUROMARK System
2022
N/A
~40
Find a Location
Who is running the clinical trial?
Neurent MedicalLead Sponsor
4 Previous Clinical Trials
461 Total Patients Enrolled
4 Trials studying Chronic Rhinitis
461 Patients Enrolled for Chronic Rhinitis
Annalise SorensenStudy DirectorNeurent Medical
3 Previous Clinical Trials
329 Total Patients Enrolled
3 Trials studying Chronic Rhinitis
329 Patients Enrolled for Chronic Rhinitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking blood thinners that cannot be stopped before a procedure.I currently have a nasal or sinus infection.My runny nose and sneezing are caused by seasonal allergies.I started a new medication for my sinus condition less than 4 weeks ago.I am a suitable candidate for a NEUROMARK® device treatment under local anesthesia.I have had symptoms of rhinitis for at least 6 months.I am 18 years old or older.I plan to have or might need an ear, nose, or throat surgery soon or within 6 months after joining the study.I had sinus or nasal surgery less than 6 months ago.I have sores inside my nose.I have been diagnosed with atrophic rhinitis.I tested negative for COVID-19 and have no symptoms.I have had severe nosebleeds needing medical help in the last 3 months.You had an allergy test within the last 5 years or are willing to have one during the study before the 6-month visit.I experience numbness in my mouth roof or have very dry eyes or nose, suggesting nerve issues in my nasal area.You are allergic to numbing medicines.I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.I have had medication-induced nasal congestion recently.I have had radiation therapy on my head or neck.I have a severe blockage in my nose that makes it hard to reach the back part.I have had surgery or treatments like RF or cryotherapy for my rhinitis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many geographical areas is the experiment taking place in?
"Presently, the trial is taking in patients from 6 different sites. These locations are California City, Bethlehem and Birmingham with 3 other cities hosting these medical centres as well. To simplify travel needs for those who join this study it's best to select a site close by."
Answered by AI
Are enrollment opportunities for this research initiative still available?
"Evidence hosted on clinicaltrials.gov shows that this trial is recruiting participants, with the initial post date being September 26th 2022 and the latest update occuring November 2nd of 2022."
Answered by AI
How many participants are accepted into this clinical research program?
"Affirmative. According to the clinicaltrials.gov website, this medical trial is actively seeking applicants and was first posted on September 26th 2022 with a most recent update occurring on November 2nd 2022. A total of 80 participants will be recruited from 6 different research centers."
Answered by AI
What do researchers intend to discover with this trial?
"Neurent Medical, the trial sponsor, has identified Safety as the primary outcome of this 6-month medical study. Additionally, they will assess Tolerability of treatment via verbal report using an Numeric Rating Scale (NRS) score and The mean change from baseline in rTNSS total score (except 6-month FU), along with Percent of subject satisfaction at follow up."
Answered by AI
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