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Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA — ARCTIC-2  

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:
OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05542082
Study type Interventional
Source Cryosa, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date August 1, 2022
Completion date April 1, 2027
View Details
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