Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07155005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Sponsor:
Calyxo, Inc.
Organization:
Study Overview
Official Title:
Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Other Therapeutic Interventions for the Treatment of Renal Stones: a Prospective, Observational Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
SCORE
Brief Summary:
The goal of this clinical trial is to evaluate the effectiveness of SURE with the CVAC System compared to other therapeutic interventions for the removal of renal stones in subjects that are candidates for URS with laser lithotripsy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: