Trials / Terminated
TerminatedNCT05542082
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA
OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- 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 efficacy study to: * Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease. * Evaluate the chronic performance of the CHILLS 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 enroll up to 3 sites in Latin America, enrollment is competitive. Up to 70 subjects will receive treatment and be followed through their 3-month visit. Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CHILLS Procedure | Cryotherapy |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-06-20
- Completion
- 2023-09-14
- First posted
- 2022-09-15
- Last updated
- 2025-06-26
Locations
2 sites across 1 country: Panama
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05542082. Inclusion in this directory is not an endorsement.