Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
ConditionObstructive Sleep Apnea of Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorCryosa, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cryosa Procedure
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov