Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Cryosa, Inc.
Summary
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.
Description
The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment is competitive but each site will be limited to 15 subjects treated.
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. To participate in this study, the subject must meet ALL of the following inclusion criteria: 2. Age 22 - 70 years 3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be \< 4 hours per night, \< 5 days/week. 4. Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide. 5. BMI ≥30 or ≤ 40 kg/m2 at enrollment 6. AHI ≥30 at enrollment based on in-lab polysomnography s…
Interventions
- DeviceCryosa Procedure
Cryotherapy
Locations (9)
- UCHealth University of ColoradoAurora, Colorado
- University of MiamiMiami, Florida
- Rush University Medical CenterChicago, Illinois
- Ochsner Baptist Medical CenterNew Orleans, Louisiana
- Albany ENT & Allergy ServicesAlbany, New York
- Specialty Physician AssociatesBethlehem, Pennsylvania