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

Not Applicable

Active, not recruiting

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Device: CHILLS Procedure

• Registration Number: NCT05542082
• Lead Sponsor: Cryosa, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Primary Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	CHILLS Procedure	CHILLS Procedure

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Procedure-Related Complications	90 Days	No serious procedure-related complications including death; loss of the airway requiring post-anesthesia care unit (PACU) re-intubation; persistent loss (more than 30 days) of tongue movement; bleeding requiring surgical intervention or transfusion; device- or procedure-related hospital re-admission; or De novo clinically significant hypoxemia (immediate or delayed) with SpO2 \< 70% for \> 10% of sleep.

Trial Locations

Locations (2)

Paitilla Medical Center; 🇵🇦 Panama City, Panama

Punta Pacifica Hospital; 🇵🇦 Panama City, Panama