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Thulium vs. Hol:YAG Laser

Primary Purpose

Nephrolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thulium Fibre Laser
Holmium:Yttrium-Aluminum-Garnet
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm Preoperative CT scan for baseline measurements Exclusion criteria: Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture Ureteral stent Uric acid component >50% on stone analysis Prior ureteroscopy within 6 weeks of current surgery Irreversible coagulopathy Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.

Sites / Locations

  • Mount Sinai WestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thulium Fibre Laser (TFL)

Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)

Arm Description

Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)

Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser

Outcomes

Primary Outcome Measures

Number of participants with stone free status
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy

Secondary Outcome Measures

Fragmentation speed
Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.
Lasing activity
Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.
Energy utilization
Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.

Full Information

First Posted
March 29, 2023
Last Updated
March 29, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05808257
Brief Title
Thulium vs. Hol:YAG Laser
Official Title
Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
February 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: A superpulsed thulium fiber laser (thulium) 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: A superpulsed thulium fiber laser (thulium) 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 Ho:YAG 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thulium Fibre Laser (TFL)
Arm Type
Experimental
Arm Description
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)
Arm Title
Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)
Arm Type
Experimental
Arm Description
Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser
Intervention Type
Device
Intervention Name(s)
Thulium Fibre Laser
Other Intervention Name(s)
TFL
Intervention Description
The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.
Intervention Type
Device
Intervention Name(s)
Holmium:Yttrium-Aluminum-Garnet
Other Intervention Name(s)
Ho:YAG
Intervention Description
The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.
Primary Outcome Measure Information:
Title
Number of participants with stone free status
Description
Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy
Time Frame
6-12 weeks postoperative
Secondary Outcome Measure Information:
Title
Fragmentation speed
Description
Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones.
Time Frame
Intraoperatively (Day 1)
Title
Lasing activity
Description
Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones.
Time Frame
Intraoperatively (Day 1)
Title
Energy utilization
Description
Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone.
Time Frame
Intraoperatively (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm Preoperative CT scan for baseline measurements Exclusion criteria: Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture Ureteral stent Uric acid component >50% on stone analysis Prior ureteroscopy within 6 weeks of current surgery Irreversible coagulopathy Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mantu Gupta, MD
Phone
212-241-1272
Email
mantu.gupta@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Gallante
Phone
212-241-1272
Email
blair.gallante@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mantu Gupta, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mantu Gupta, MD
Phone
212-241-1272
Email
mantu.gupta@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Mantu Gupta

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.

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Thulium vs. Hol:YAG Laser

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