Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02683993
Status:
COMPLETED
Last Update Posted:
2025-11-07
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
Detailed Description:
This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: