N/A
N=171
A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT04505956 ↗Enrolled (actual)
171
Serious AEs
7.2%
Results posted
Oct 2024
Primary outcome: Primary: Operative Time — 36; 37 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Holmium laser lithotripsy with Moses Technology (Device); Holmium laser lithotripsy without Moses Technology (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operative Time |
36; 37 | — |
| SECONDARY Stone Retropulsion |
18; 27; 32; 21; 11; 9 | — |
Summary
Flexible ureteroscopy is characterized as first-line therapy for the treatment of renal stones < 2 cm in size. This involves passing a flexible endoscope into the renal pelvis through the urethra, bladder and ureter in a retrograde fashion. Holmium: YAG laser remains the preferred energy modality to subsequently break stones of this size into fragments small enough to remove or pass spontaneously through the ureter. Advances in the understanding of laser energy delivery have led to the recent commercialization of the "Moses Effect" - the creation of vapor bubbles/cavities between the laser fiber tip and the target through which laser energy can more efficiently travel. Lumenis was the first to optimize this laser phenomenon and market it as "Moses Technology" in their Lumenis Pulse P120H laser system. This system is already FDA approved through the 510K pathway and is commercially available. The purpose of this study is to evaluate the potential of Moses laser technology to reduce operative time compared to non-Moses settings for ureteroscopic treatment of nephrolithiasis.
Eligibility Criteria
Inclusion Criteria
- Solitary renal stone 8 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 8-20 mm is required
- Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
- Must be 18 years or older
- Must be able to give consent
Exclusion Criteria
- Concomitant stones in the ureter
- Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
- Prior radiotherapy to the abdomen or pelvis
- Neurogenic bladder or spinal cord injury
- Pregnancy
- Untreated UTI
Data sourced from ClinicalTrials.gov (NCT04505956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.