Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT05814133
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thulium Fiber Laser Prospective Trial
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
Study Overview
Official Title:
Prospective Clinical Trial To Evaluate The Thulium Fiber Laser For The Ureteroscopic Treatment Of Nephrolithiasis
Status:
RECRUITING
Status Verified Date:
2024-01
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:
TFL
Brief Summary:
This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
Detailed Description:
Flexible ureteroscopy is considered the first-line therapy for renal stones \< 2 cm. The Holmium: YAG laser (Ho:YAG) is established as gold standard in urology practice. Despite its limitations, it is widely used to break stones into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the 'Thulium Fiber Laser' (TFL) with unique characteristics and promising improvements of ablation efficiency, dusting capacity, operating time and deflection. A a multi-center, prospective clinical trial to further assess those advantages for the lithotripsy of kidney stones will be conducted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: