NCT06306222

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2026

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

December 29, 2023

Last Update Submit

March 5, 2024

Conditions

Kidney StoneUreteral Stone

Outcome Measures

Primary Outcomes (1)

  • Lithotripsy speed

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Stone free rate

    3 months after the procedure

Study Arms (2)

Thulium fiber laser (TFL) lithotripsy

EXPERIMENTAL

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

Device: Laser lithotripsy

Holmium:YAG laser lithotripsy

ACTIVE COMPARATOR

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

Device: Laser lithotripsy

Interventions

Laser lithotripsyDEVICE

Ureteroscopic laser lithotripsy

Holmium:YAG laser lithotripsyThulium fiber laser (TFL) lithotripsy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal/ureteral stones \> 4 mm

You may not qualify if:

  • Anatomical abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Kidney CalculiUreterolithiasis

Interventions

Lithotripsy, Laser

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsLithotripsyAblation TechniquesSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

D'Arma Alessia

CONTACT

+390226435506darma.alessia@hsr.it

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
Principal investigator

Study Record Dates

First Submitted

December 29, 2023

First Posted

March 12, 2024

Study Start

November 23, 2023

Primary Completion

November 23, 2025

Study Completion

February 23, 2026

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)