Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808257
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2023-03-29
Brief Title:
Thulium vs HolYAG Laser
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Superpulsed Thulium Fiber Laser VS Pulse Modulated High Power HolmiumYAG Laser For Retrograde Intrarenal Surgery
Status:
COMPLETED
Status Verified Date:
2024-02
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 is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease
1 A superpulsed thulium fiber laser thulium
2 A pulse modulated high power holmium laser Holmium
1 A superpulsed thulium fiber laser thulium
2 A pulse modulated high power holmium laser Holmium
Detailed Description:
This is a randomized prospective study The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease The researchers will compare the following two systems
1 A superpulsed thulium fiber laser thulium
2 A pulse modulated high power holmium laser Holmium
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between 5mm to 20 mm Subjects will be randomized to undergo lithotripsy with either HoYAG or Thulium lasers
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery
1 A superpulsed thulium fiber laser thulium
2 A pulse modulated high power holmium laser Holmium
The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between 5mm to 20 mm Subjects will be randomized to undergo lithotripsy with either HoYAG or Thulium lasers
All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care
The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery
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?:
False
Is an FDA AA801 Violation?:
None