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.
Willing and capable of providing informed consent
Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies
Willing and capable of completing all questionnaires
Age is 22 to 70 years old
Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
Any reason the investigator deems the subject unfit for participation in the study
Actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender or >65 years of age
Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure
Single group
Cryosa Procedure
DeviceThe purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA).
Incidence of Serious Procedure or Device/Treatment Related Events
Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure
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This trial is not recruiting at the moment. You can still explore other options:
