Thulium vs. Hol:YAG Laser

Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery

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)

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis
• Intervention / Treatment: Device: Thulium Fibre Laser; Device: Holmium:Yttrium-Aluminum-Garnet

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 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thulium Fibre Laser (TFL); Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)	Device: Thulium Fibre Laser; 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.; Other Names: TFL
Experimental: Holmium:Yttrium-Aluminum-Garnet (Ho:YAG); Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser	Device: Holmium:Yttrium-Aluminum-Garnet; 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.; Other Names: Ho:YAG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stone Free Status	Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy	6-12 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperatively (Day 1)
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.	Intraoperatively (Day 1)
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.	Intraoperatively (Day 1)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: STUDY-22-01521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.

Drug and device information, study documents

• 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