Trials / Recruiting
RecruitingNCT06008626
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Cryosa, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
Detailed description
The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment is competitive but each site will be limited to 15 subjects treated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cryosa Procedure | Cryotherapy |
Timeline
- Start date
- 2023-09-12
- Primary completion
- 2026-06-30
- Completion
- 2028-03-31
- First posted
- 2023-08-23
- Last updated
- 2026-02-24
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06008626. Inclusion in this directory is not an endorsement.