Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864652
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-09-15
First Post:
2021-03-17
Brief Title:
Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA
Sponsor:
Cryosa Inc
Organization:
Cryosa Inc
Study Overview
Official Title:
Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea OSA ARCTIC-1
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCTIC-1
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None