Comparing the Efficacy of Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Renal/ureteral stones \> 4 mm
Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
D'Arma Alessia
darma.alessia@hsr.it
+390226435506
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2026-02-23
Participants
Target number of participants: 120
Treatments
Experimental: Thulium fiber laser (TFL) lithotripsy
Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.
Active_comparator: Holmium:YAG laser lithotripsy
Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele