Trials / Completed
CompletedNCT04154605
ClariFix Rhinitis RCT
ClariFix Rhinitis Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Stryker Instruments · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
Detailed description
A prospective, multicenter, randomized, sham-controlled, single-blind (participants) study to demonstrate the superiority of treatment with the ClariFix cryotherapy device for reducing symptoms when compared with a sham treatment in patients with chronic rhinitis. The ClariFix device is a Class II FDA-cleared medical device that is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ClariFix cryotherapy | Bilateral freeze ablation of nasal tissue using the ClariFix device. |
| DEVICE | Sham ClariFix cryotherapy | Bilateral sham ablation procedure using the ClariFix device. |
Timeline
- Start date
- 2019-11-05
- Primary completion
- 2021-03-31
- Completion
- 2025-01-19
- First posted
- 2019-11-06
- Last updated
- 2025-03-26
- Results posted
- 2021-09-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04154605. Inclusion in this directory is not an endorsement.