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OpenTrials
Completed

NCT Number: NCT05808257

Thulium vs. Hol:YAG Laser

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai West

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thulium Fibre Laser

Device

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

Holmium:Yttrium-Aluminum-Garnet

Device

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

Primary outcomes

  1. Number of Participants With Stone Free Status

    Time frame: 6-12 weeks postoperative

    Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy

Secondary outcomes

  1. Fragmentation Speed

    Time frame: Intraoperatively (Day 1)

    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.

  2. Lasing Activity

    Time frame: Intraoperatively (Day 1)

    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.

  3. Energy Utilization

    Time frame: Intraoperatively (Day 1)

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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