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Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA — ARCTIC-1  

Obstructive Sleep Apnea of Adult Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04864652
Study type Interventional
Source Cryosa, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date November 30, 2020
Completion date December 1, 2024
View Details
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