OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2) (ARCTIC-2)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2027
  • participants needed
    50
  • sponsor
    Cryosa, Inc.
Updated on 17 October 2022

Summary

This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:

  • Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
  • Evaluate the chronic performance of the CHILLS 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 enroll up to 3 sites in Latin America, enrollment is competitive.

Up to 70 subjects will receive treatment and be followed through their 3-month visit.

Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.

Details
Condition Obstructive Sleep Apnea of Adult
Treatment CHILLS Procedure
Clinical Study IdentifierNCT05542082
SponsorCryosa, Inc.
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Likely suffer moderate to severe OSA based on history and physical or have an established
diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study
A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10
and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility
Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy
BMI of 25 - 40 kg/m2 at enrollment
Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of
clinical symptoms for long COVID-19 relating to deterioration of taste, smell

Exclusion Criteria

Unable or incapable of providing informed written consent
Unwilling or incapable of returning to all follow-up visits and sleep studies, including
evaluation procedures and filling out questionnaires
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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