Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-07 @ 8:59 PM
Study NCT ID:
NCT07225933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Sponsor:
Calyxo, Inc.
Organization:
Study Overview
Official Title:
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
REASON
Brief Summary:
This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.
Detailed Description:
The objective of this study is observation of the safety and efficacy of subjects who underwent SURE procedure using the CVAC System or FANS for the removal of kidney stones in candidates for URS with laser lithotripsy. Efficacy will be observed by reviewing stone free status on standard of care post-procedure imaging. Safety will be observed by reviewing procedural information and if subjects had urologic events leading to Emergency Department (ED) visits, hospitalization, or retreatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: