Trials / Completed
CompletedNCT04769596
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 143 (actual)
- Sponsor
- Neurent Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis
Detailed description
The MERIDIEN Study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the NEUROMARK™ System in patients with Chronic Rhinitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NEUROMARK™ System | The NEUROMARK™ System is designed to deliver energy to the nasal cavity intended to interrupt nasal nerves aimed to reduce symptoms related to Chronic Rhinitis. |
| DEVICE | Sham Device | A Sham device will be used in the nasal cavity |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2023-05-10
- Completion
- 2023-05-10
- First posted
- 2021-02-24
- Last updated
- 2023-07-19
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04769596. Inclusion in this directory is not an endorsement.