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

NCT ID: NCT06306222

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2026-02-23

Brief Summary

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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

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Conditions

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Kidney Stone Ureteral Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Thulium fiber laser (TFL) lithotripsy

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

Group Type EXPERIMENTAL

Laser lithotripsy

Intervention Type DEVICE

Ureteroscopic laser lithotripsy

Holmium:YAG laser lithotripsy

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

Group Type ACTIVE_COMPARATOR

Laser lithotripsy

Intervention Type DEVICE

Ureteroscopic laser lithotripsy

Interventions

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Laser lithotripsy

Ureteroscopic laser lithotripsy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Renal/ureteral stones \> 4 mm

Exclusion Criteria

* Anatomical abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Eugenio Ventimiglia

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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D'Arma Alessia

Role: CONTACT

+390226435506

Facility Contacts

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Alessia D'Arma

Role: primary

Other Identifiers

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GR-2021-12375430

Identifier Type: -

Identifier Source: org_study_id

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