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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36-month follow-up
Awards & highlights
Study Summary
This trial will collect data on how a medical device works in people with chronic rhinitis.
Who is the study for?
This trial is for adults over 18 with chronic rhinitis who are about to receive the NEUROMARK System treatment. Participants should have moderate to severe runny nose and mild to severe nasal congestion, scoring at least 5 out of 12 on a symptom scale. They must consent and follow study procedures.Check my eligibility
What is being tested?
The NEUROMARK Registry Study is evaluating the real-world use of the NEUROMARK System in treating chronic rhinitis. It's an observational study collecting data from multiple centers on how well this system works after it has been sold.See study design
What are the potential side effects?
While specific side effects aren't listed here, patients with a history of frequent or significant nosebleeds requiring medical help, especially within the last three months, cannot participate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.
Select...
I am 18 years old or older.
Select...
I am scheduled for treatment with the NEUROMARK System as recommended.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
Safety - incidence of device- and/or procedure-related serious adverse
Trial Design
1Treatment groups
Experimental Treatment
Group I: NEUROMARK TreatmentExperimental Treatment1 Intervention
Interventional registry to collect real world data - 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
391 Total Patients Enrolled
4 Trials studying Chronic Rhinitis
391 Patients Enrolled for Chronic Rhinitis
Annalise SorensenStudy DirectorNeurent Medical
3 Previous Clinical Trials
259 Total Patients Enrolled
3 Trials studying Chronic Rhinitis
259 Patients Enrolled for Chronic Rhinitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe nosebleeds needing medical help in the last 3 months.I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.I am 18 years old or older.I am scheduled for treatment with the NEUROMARK System as recommended.
Research Study Groups:
This trial has the following groups:- Group 1: NEUROMARK 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.
What is the current recruitment count for this research study?
"In order to move forward with this research, Neurent Medical requires 150 eligible participants. These patients can be found at two locations: Sacramento ENT in Roseville, California and Ogden Clinic in Ogden, Utah."
Answered by AI
How many facilities are managing the clinical trial?
"This medical research project is welcoming participants at a few select locations including Sacramento ENT in Roseville, California, Ogden Clinic in Ogden, Utah and Metropolitan ENT in Alexandria, Virginia."
Answered by AI
Are any new participants being taken in for this research study?
"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which first went live on June 12th 2023, is now recruiting volunteers for participation. 150 participants need to be recruited from 4 different medical sites."
Answered by AI
Who else is applying?
What site did they apply to?
Sensa Health
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What questions have other patients asked about this trial?
How long is the first visit and what is the compensation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have a bad runny nose.
PatientReceived 1 prior treatment
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