Thulium vs. Hol:YAG Laser

NCT05808257 | Completed Results FDA Device

• 1 other identifier: STUDY-22-01521
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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. 1.A superpulsed thulium fiber laser (thulium)
2. 2.A pulse modulated high power holmium laser (Holmium)

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fragmentation Speed

  Intraoperatively (Day 1)

• Lasing Activity

  Intraoperatively (Day 1)

• Energy Utilization

  Intraoperatively (Day 1)

Study Arms (2)

Thulium Fibre Laser (TFL)

EXPERIMENTAL

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

Device: Thulium Fibre Laser

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

EXPERIMENTAL

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

Device: Holmium:Yttrium-Aluminum-Garnet

Interventions

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.

Also known as: TFL

Thulium Fibre Laser (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.

Also known as: Ho:YAG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing single stage unilateral RIRS for total stone burden volume \>5mm to \< 20 mm
• Preoperative CT scan for baseline measurements

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Mantu Gupta
• Organization: Icahn School of Medicine at Mount Sinai

mantu.gupta@mountsinai.org

212-241-1272

Study Officials

• Mantu Gupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: January 7, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)