NEUROMARK System for Chronic Rhinitis

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Neurent Medical

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial is testing a new device called the NEUROMARK System to help people with chronic rhinitis, a condition where the nose stays inflamed for a long time. The device works by calming the nerves in the nose to reduce inflammation and improve symptoms.

Eligibility Criteria

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.

Inclusion Criteria

Be willing and able to comply with all study elements, as indicated by written informed consent

I am a suitable candidate for a NEUROMARK® device treatment under local anesthesia.

I have had symptoms of rhinitis for at least 6 months.

+4 more

Exclusion 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.

+15 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Subjects will undergo treatment with the NEUROMARK System

NEUROMARK System is already approved in United States for the following indications:

🇺🇸 Approved in United States as NEUROMARK System for: