Clinical trial NCT04505956: A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
Official title: Prospective Randomized Double Blind Clinical Trial to Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology for the Ureteroscopic Treatment of Nephrolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Keywords: Ureteroscopy
Nephrolithiasis
Kidney Stone
Lithotripsy
Holmium
Moses
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Operative Time
timeFrame: Beginning to end of procedure time, assessed up to 2 hours
Secondary outcomes:
measure: Stone Retropulsion
timeFrame: First 20 seconds of laser lithotripsy
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Nicole L Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.
citation: Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Interventional Treatment for Urolithiasis. Eur Urol. 2016 Mar;69(3):475-82. doi: 10.1016/j.eururo.2015.07.041. Epub 2015 Sep 4.
citation: Ventimiglia E, Traxer O. What Is Moses Effect: A Historical Perspective. J Endourol. 2019 May;33(5):353-357. doi: 10.1089/end.2019.0012.
citation: Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, Nelson H. NASA-Task Load Index Differentiates Surgical Approach: Opportunities for Improvement in Colon and Rectal Surgery. Ann Surg. 2020 May;271(5):906-912. doi: 10.1097/SLA.0000000000003173.
citation: Dias RD, Ngo-Howard MC, Boskovski MT, Zenati MA, Yule SJ. Systematic review of measurement tools to assess surgeons' intraoperative cognitive workload. Br J Surg. 2018 Apr;105(5):491-501. doi: 10.1002/bjs.10795. Epub 2018 Feb 21.
citation: Elhilali MM, Badaan S, Ibrahim A, Andonian S. Use of the Moses Technology to Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. J Endourol. 2017 Jun;31(6):598-604. doi: 10.1089/end.2017.0050. Epub 2017 Apr 25.
citation: Ibrahim A, Badaan S, Elhilali MM, Andonian S. Moses technology in a stone simulator. Can Urol Assoc J. 2018 Apr;12(4):127-130. doi: 10.5489/cuaj.4797. Epub 2017 Dec 22.
citation: Mullerad M, Aguinaga JRA, Aro T, Kastin A, Goldin O, Kravtsov A, Assadi A, Badaan S, Amiel GE. Initial Clinical Experience with a Modulated Holmium Laser Pulse-Moses Technology: Does It Enhance Laser Lithotripsy Efficacy? Rambam Maimonides Med J. 2017 Oct 16;8(4):e0038. doi: 10.5041/RMMJ.10315.
citation: Stern KL, Monga M. The Moses holmium system - time is money. Can J Urol. 2018 Jun;25(3):9313-9316.
citation: Humphreys MR, Shah OD, Monga M, Chang YH, Krambeck AE, Sur RL, Miller NL, Knudsen BE, Eisner BH, Matlaga BR, Chew BH. Dusting versus Basketing during Ureteroscopy-Which Technique is More Efficacious? A Prospective Multicenter Trial from the EDGE Research Consortium. J Urol. 2018 May;199(5):1272-1276. doi: 10.1016/j.juro.2017.11.126. Epub 2017 Dec 16.