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Thulium vs. Hol:YAG Laser

NCT05808257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-01-29

Study results available
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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)

Conditions

  • Nephrolithiasis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mantu Gupta, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2024-02-01
Completion
2024-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808257 on ClinicalTrials.gov