Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320860
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-20
First Post:
2024-03-08
Brief Title:
FlexStone Enabled Kidney Stone Retrieval
Sponsor:
EndoTheia
Organization:
EndoTheia
Study Overview
Official Title:
FlexStone Enabled Kidney Stone Retrieval
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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 study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets
Detailed Description:
The clinical practice at Vanderbilt University Medical Center will perform standard flexible ureteroscopy fURS procedures using conventional stone retrieval baskets the EndoTheia FlexStone basket laser fibers for intracorporeal lithotripsy and any other fURS accessory devices as determined by the surgeon If renal calculi are present which the physician deems retrieval of would benefit from the added aimability of the EndoTheia FlexStone basket will be used
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