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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Cryotherapy
Punta Pacifica Hospital
Panama City, Provincia de Panamá, Panama
Paitilla Medical Center
Panama City, Panama
Incidence of Serious Procedure-Related Complications
No serious procedure-related complications including death; loss of the airway requiring post-anesthesia care unit (PACU) re-intubation; persistent loss (more than 30 days) of tongue movement; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 \< 70% for \> 10% of sleep.
Time frame: 90 Days
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