Trials / Completed
CompletedNCT05591989
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Neurent Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NEUROMARK System | The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2025-08-05
- Completion
- 2025-08-05
- First posted
- 2022-10-24
- Last updated
- 2026-03-20
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05591989. Inclusion in this directory is not an endorsement.