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Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

NCT05542082 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Adult

Interventions

DEVICE

CHILLS Procedure

Cryotherapy

Sponsors & Collaborators

  • Cryosa, Inc.

    lead INDUSTRY

Principal Investigators

  • Stella Rowley, MD · San Fernando Specialized Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-06-20
Completion
2023-09-14
FDA Device
Yes

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542082 on ClinicalTrials.gov