Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhini… (NCT05324397) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)
United States36 participantsStarted 2022-03-14
Plain-language summary
The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Confirmation of moderate to severe symptoms of rhinorrhea. (VAS NSS score for runny nose ≥ 5.0 and rTNSS score for runny nose ≥ 2).
* Confirmation of mild to severe symptoms of nasal congestion. (VAS NSS score ≥ 2.5 for stuffy nose (congestion) and rTNSS score of ≥ 1).
* Confirmation that the total combined VAS NSS score is ≥ 10 for nasal congestion and runny nose.
* 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.).
* Nasal anatomy appropriate to receive the NEUROMARK™ System.
* Subject is experiencing long term chronic rhinitis. Subject has been experiencing symptoms of rhinitis for at least 6 months prior to enrollment, defined as: rhinorrhea, anterior runny nose AND congestion, blockage (st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month
Timeframe: 1 month
2
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months
Timeframe: 3 months
3
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months