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

NCT05542082 | Terminated DMC FDA Device

• 1 other identifier: 10721
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Procedure-Related Complications

  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.

  90 Days

Study Arms (1)

Single Arm

EXPERIMENTAL

CHILLS Procedure

Device: CHILLS Procedure

Interventions

CHILLS Procedure DEVICE

Cryotherapy

Single Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cryosa, Inc.: lead

Study Sites (2)

Punta Pacifica Hospital

Panama City, Provincia de Panamá, Panama

Location

Paitilla Medical Center

Panama City, Panama

Location

Study Officials

• Stella Rowley, MD

  San Fernando Specialized Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: August 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: September 14, 2023
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)