Kidney Stone
Conditions
Brief summary
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.
Interventions
DEVICEMoses Holmium:YAG laser
Ho:YAG with Moses pulse modulation
DEVICEThulium:YAG laser
p-Tm:YAG laser lithotripsy with long pulse mode
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The case coordinator will inform the operating surgeon of the assigned laser before the procedure begins. Study participants will remain blinded to the laser assignment. Outcome assessments, including imaging based evaluation, will be performed by personnel who are blinded to treatment allocation.
Intervention model description
A simple randomization scheme will be used to assign a laser to each case according to a predefined allocation scheme. Randomization will be conducted prior to surgery, and allocation will be concealed until the start of the operating room workflow.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Bilateral ureteroscopy will be permitted , but only the side(s) where the FANS access sheath was used (per surgeon discretion) will be included in the study, however can include both sides as separate units. Subjects will be enrolled only once in the study. No subject will be enrolled more than a single time. For patients undergoing bilateral ureteroscopy, each kidney will be considered a separate unit for stone-related assessments. Peri-patient measures, such as operative time, will be recorded at the patient level. Bilateral cases will be clearly identified and handled consistently to ensure accurate and appropriate interpretation of study outcomes. * Must be a patient of one of the surgeons participating in this study.
Exclusion criteria
* Concomitant stones in the ureter * Prior radiotherapy to the abdomen or pelvis * Neurogenic bladder or spinal cord injury * Pregnancy * Untreated urinary tract infection (UTI) * Anatomical abnormalities (including, but not limited to, bifid system, pelvic kidney, horseshoe kidney) * Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone-free rate (absence of any fragments ≥ 2mm) | Month 1 |
| Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month) | Month 1 |
Secondary
| Measure | Time frame |
|---|---|
| Total operative time | From first insertion of instruments to final removal of all instruments (up to 3 hours) |
| Lasing time | From start of lasing to end of lasing (up to 1 hour) |
| Laser energy expended (J) | From start of lasing to end of lasing (up to 1 hour) |
| Laser energy expended per stone volume | From start of lasing to end of lasing (up to 1 hour) |
| Stone volume per lasing time | From start of lasing to end of lasing (up to 1 hour) |
Countries
United States
Contacts
CONTACTEsteban Emiliani, MD, PhD
CONTACTRozalba Gogaj, MD, MPH
PRINCIPAL_INVESTIGATOREsteban Emiliani, MD, PhD
NYU Langone Health
Outcome results
None listed