Thulium vs. Hol:YAG Laser

Mount Sinai Health System

Status: Completed

Conditions: Nephrolithiasis

Treatments: Device: Thulium Fibre Laser; Device: Holmium:Yttrium-Aluminum-Garnet

Study type: Interventional

Funder types: Other

Identifiers

NCT05808257

STUDY-22-01521

Details and patient eligibility

About

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)

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Thulium Fibre Laser (TFL)

Experimental group

Description:

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

Treatment:

Device: Thulium Fibre Laser

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

Experimental group

Description:

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

Treatment:

Device: Holmium:Yttrium-Aluminum-Garnet