Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease

Not Applicable

Recruiting

• Conditions: Kidney Stone; Ureteral Stone
• Interventions: Device: Laser lithotripsy

• Registration Number: NCT06306222
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2023-12-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-11-23
• Study Completion: 2026-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Renal/ureteral stones > 4 mm

Exclusion Criteria

• Anatomical abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium fiber laser (TFL) lithotripsy	Laser lithotripsy	Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.
Holmium:YAG laser lithotripsy	Laser lithotripsy	Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.

Primary Outcome Measures

Name	Time	Method
Lithotripsy speed	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Stone free rate	3 months after the procedure

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy