Health TrialsbyHealthPanel

Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (OASIS)

ConditionsObstructive Sleep Apnea (OSA)Sleep Apnea - ObstructiveOSA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorCryosa, Inc.

About this trial

The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant age is 22 years and older

Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD)

Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA/MA ≤ 25%)

Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies

Disqualifiers

Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing

Any reason for which, in the judgment of the investigator, the participant is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study (e.g. uncontrolled Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease)

Participant has a BMI > 40 kg/m2 at enrollment

Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryosa Procedure

    Device

    Cryotherapy

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Cryosa ProcedureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Endpoint

The safety of the Cryosa System will be assessed via the description of all reported adverse events. Adverse events will be summarized by seriousness, severity and relatedness to the device and/or procedure

Time frame
6 Months, 12 Months
2

Primary Co-Efficacy AHI Responder Endpoint

Reduction in AHI of ≥ 50% or 15 points improvement at 6 months compared to baseline.

Time frame
6 Months
3

Primary Co-Efficacy ODI Responder Endpoint

Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline.

Time frame
6 Months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cryosa, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: