Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhin… (NCT05591989) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)
United States80 participantsStarted 2022-09-26
Plain-language summary
The PARAGON 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
. Be ≥18 years of age.
. Have been experiencing rhinitis symptoms for a minimum of 6 months.
. Have moderate to severe symptoms of runny 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 baseline.
. Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E \[IgE test\]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit.
. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
. Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment.
. Be willing and able to comply with all study elements, as indicated by written informed consent.
Exclusion criteria
. Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
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
Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy]
. Have had previous sinus or nasal surgery within 6 months of study enrollment.
. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
. Have an active nasal or sinus infection.
. Have nasal mucosal erosion/ulceration.
. Have rhinitis symptoms that are due to seasonal allergies only.
. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.