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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 50 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 45 days with evaluation intervals at discharge, 7 days, 30 days and 45 days post procedure. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04864652
Study type Interventional
Source Cryosa, Inc.
Contact Kristine Selander, MS
Phone 7632673202
Email [email protected]
Status Recruiting
Phase N/A
Start date November 30, 2020
Completion date September 1, 2021

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