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

San Donato Group (GSD)

Status: Enrolling

Conditions: Kidney Stone; Ureteral Stone

Treatments: Device: Laser lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06306222

GR-2021-12375430

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renal/ureteral stones > 4 mm

Exclusion criteria

• Anatomical abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Thulium fiber laser (TFL) lithotripsy

Experimental group

Description:

Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.

Treatment:

Device: Laser lithotripsy

Holmium:YAG laser lithotripsy

Active Comparator group

Description:

Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.

Treatment:

Device: Laser lithotripsy