Thulium vs. Hol:YAG Laser

Nephrolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05808257
• Other study ID #: STUDY-22-01521
• Status: Completed
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)