NCT05808257

Thulium vs. Hol:YAG Laser

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-01-07
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-04-11
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study