NCT04864652

Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA

Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Cryosa, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.

Detailed description

The study is a safety and dose titration study to determine the optimum dose of Cryosa CHILLS cryotherapy in patients with clinically diagnosed moderate or severe OSA. Up to 70 subjects are planned to be enrolled and treated with the device at up to 3 clinical sites in Latin America. Subjects will be followed for 90 days with evaluation intervals at discharge, 7 days, 30 days and 90 days post-procedure. Subjects agreeing to long-term follow-up will complete visits every 6 months through 2 years post-procedure.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	CHILLS Procedure	CHILLS Cryotherapy procedure

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-08-25
• Completion: 2023-05-06
• First posted: 2021-04-29
• Last updated: 2025-06-26

Locations

2 sites across 2 countries: Panama, Paraguay

Regulatory

• FDA-regulated device study