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Completed

NCT Number: NCT04505956

A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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About this study

There is ongoing debate on the optimal means of laser stone fragmentation, and Moses technology is the latest advancement to raise questions regarding clinical utility. Initial preclinical studies demonstrated significantly reduced stone retropulsion and higher stone ablation volume with Moses technology, leading to the conclusion that the system allows more efficient laser lithotripsy. Human studies also showed that laser lithotripsy with Moses technology utilized laser energy in less time for stone fragmentation: 10.0 (2.6-15.0) min without vs 6.0 (2.8-13.0) min with Moses technology.

Others have evaluated the cost effectiveness of Moses technology in their own cohort of 40 patients who underwent standard laser lithotripsy by comparing a 35% projected decrease in procedure time against the cost of the Moses laser fiber and machine. Mean stone size was 10.2 mm in this group of patients, and mean lasing time was 3.0 minutes. While a significant positive association was seen between stone size and laser time, cost analysis failed to show a benefit in using Moses technology across sizes.

To date, there are limited clinical data obtained through rigorous study methodology. In addition, knowledge gaps remain regarding the effect of Moses technology on other clinically meaningful outcomes such as stone-free rate. Therefore, the investigators propose a multi-center, prospective, randomized, double blind clinical trial to further assess the effect of Moses technology for lithotripsy. The investigators aim to study a broader range of outcomes which will be facilitated by being the largest study to date. The investigators also aim to study novel outcomes such as grading retropulsion and visibility by independent blinded review as well as effects of Moses technology on independently reducing surgeon burnout. Indeed, a randomized, double blind clinical trial evaluating Moses technology in 66 patients undergoing ureteroscopy was presented as a 2018 European Association of Urology abstract. While this single center study demonstrated safety and reduced fragmentation time as well as procedure time using Moses technology, it did not show a significant difference in stone-free rates. This study is also yet to be published as a manuscript.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holmium laser lithotripsy with Moses Technology

Device

Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.

Other names: Moses Laser Lithotripsy

Holmium laser lithotripsy without Moses Technology

Device

Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.

Other names: Standard Laser Lithotripsy

Primary outcomes

  1. Operative Time

    Time frame: Beginning to end of procedure time, assessed up to 2 hours

    Total operative times between Moses holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the ureteroscopic treatment of renal stones using a dusting technique

Secondary outcomes

  1. Stone Retropulsion

    Time frame: First 20 seconds of laser lithotripsy

    Stone movement during laser lithotripsy will be recorded on video and graded on a Likert scale by blinded reviewers. Video could not be taken for all trial patients. Videos were obtained and stored when feasible.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Prospective Randomized Double Blind Clinical Trial to Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology for the Ureteroscopic Treatment of Nephrolithiasis

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2020
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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