Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 3:58 AM
Study NCT ID:
NCT07021833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)
Sponsor:
Cryosa, Inc.
Organization:
Study Overview
Official Title:
Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
None
Brief Summary:
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.
Detailed Description:
The study will treat up to 30 subjects at up to 5 sites in Australia.
Study Oversight
Has Oversight DMC:
True
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?: