Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access Sheaths
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moses Holmium:YAG laser, Thulium:YAG laser.
- Who it may be relevant to
- Registry conditions: Kidney Stone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With Flexible And Navigable Ureteric Access Sheath (FANS)
Overview
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
- Device Moses Holmium:YAG laser
Ho:YAG with Moses pulse modulation - Device Thulium:YAG laser
p-Tm:YAG laser lithotripsy with long pulse mode
Primary outcome measures
- Stone-free rate (absence of any fragments ≥ 2mm) [Time frame: Month 1]
- Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month) [Time frame: Month 1]
Secondary outcome measures (5)
- Total operative time [Time frame: From first insertion of instruments to final removal of all instruments (up to 3 hours)]
- Lasing time [Time frame: From start of lasing to end of lasing (up to 1 hour)]
- Laser energy expended (J) [Time frame: From start of lasing to end of lasing (up to 1 hour)]
- Laser energy expended per stone volume [Time frame: From start of lasing to end of lasing (up to 1 hour)]
- Stone volume per lasing time [Time frame: From start of lasing to end of lasing (up to 1 hour)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mayo Clinic Arizona — Phoenix
- NYU Langone Health — New York
Identifiers
NCT: NCT07516106 · 25-01646