Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (NCT06008626) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
United States25 participantsStarted 2023-09-12
Plain-language 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.
Who can participate
Age range22 Years – 70 Years
SexALL
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Inclusion criteria
✓. To participate in this study, the subject must meet ALL of the following inclusion criteria:
✓. Age 22 - 70 years
✓. 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.
✓. 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.
✓. BMI ≥30 or ≤ 40 kg/m2 at enrollment
✓. AHI ≥30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study Is geographically stable and in close proximity to the site
✓. Able and willing to provide written consent to participate in the study
Exclusion criteria
✕. Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event
✕. Actively taking ACEs/ARBs
✕. Actively undergoing immunotherapy (Allergy shots)\*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.
✕. Severe uncontrolled asthma
What they're measuring
1
Incidence of Serious Procedure or Device/ Treatment Related Events