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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306222
Other study ID # GR-2021-12375430
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 23, 2023
Est. completion date February 23, 2026

Study information

Verified date March 2024
Source IRCCS San Raffaele
Contact D'Arma Alessia
Phone +390226435506
Email darma.alessia@hsr.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date February 23, 2026
Est. primary completion date November 23, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Renal/ureteral stones > 4 mm Exclusion Criteria: - Anatomical abnormalities

Study Design


Intervention

Device:
Laser lithotripsy
Ureteroscopic laser lithotripsy

Locations

Country Name City State
Italy IRCCS Ospedale San Raffaele Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lithotripsy speed Through study completion, an average of 1 year
Secondary Stone free rate 3 months after the procedure
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