About this trial
The purpose of this study is to compare two laser technologies that are routinely used during ureteroscopy for the treatment of kidney stones. Specifically, this study will compare a pulsed Thulium:YAG laser to a pulse-modulated Holmium:YAG laser (Moses technology) to evaluate how effective and safe they are when used to break kidney stones.
Primary endpoints include stone-free rate and the zero stone-free rate at a standardized postoperative. Secondary endpoints include total operative time, lasing time (s), laser energy expended (J), efficiency (laser energy expended/stone volume; stone volume/lasing time). These endpoints aim to provide a comprehensive assessment of the clinical effectiveness and procedural efficiency of the two laser systems.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
Must be 18 years or older
Must be able to give consent
Disqualifiers
Concomitant stones in the ureter
Prior radiotherapy to the abdomen or pelvis
Neurogenic bladder or spinal cord injury
Pregnancy
Trial design
Parallel
Treatments tested in this trial
Moses Holmium:YAG laser
DeviceHo:YAG with Moses pulse modulation
Thulium:YAG laser
Devicep-Tm:YAG laser lithotripsy with long pulse mode
Treatment groups
Trial outcomes
Primary outcomes
Stone-free rate (absence of any fragments ≥ 2mm)
Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)
Secondary outcomes
Total operative time
Lasing time
Laser energy expended (J)
Laser energy expended per stone volume
Sponsors and contacts
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