Thulium vs. Hol:YAG Laser

Not Applicable

Completed

• Conditions: Nephrolithiasis
• Interventions: Device: Thulium Fibre Laser

• Registration Number: NCT05808257
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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:

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.

Study Timeline

• Study Start: 2022-01-07
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium Fibre Laser (TFL)	Thulium Fibre Laser	Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fragmentation speed	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.
Energy utilization	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.
Lasing activity	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.

Trial Locations

Locations (1)

Mount Sinai West; 🇺🇸 New York, New York, United States