Stopped: Cryosa elected to terminate the study and discontinue further follow-up after all willing and available subjects had completed the 6-month follow-up. The primary endpoint of 90-days of follow up was met for all active subjects.
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of Serious Procedure-Related Complications
Timeframe: 90 Days