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

NCT04505956 | Completed Results DMC FDA Device

• 1 other identifier: Moses Ureteroscopy RCT
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 6

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.

Conditions

Nephrolithiasis

Keywords

Ureteroscopy; Nephrolithiasis; Kidney Stone; Lithotripsy; Holmium; Moses

Outcome Measures

Primary Outcomes (1)

• Operative Time

  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

  Beginning to end of procedure time, assessed up to 2 hours

Secondary Outcomes (1)

• Stone Retropulsion

  First 20 seconds of laser lithotripsy

Study Arms (2)

Moses Laser Lithotripsy

EXPERIMENTAL

Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology.

Device: Holmium laser lithotripsy with Moses Technology

Standard Laser Lithotripsy

ACTIVE COMPARATOR

Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings.

Device: Holmium laser lithotripsy without Moses Technology

Interventions

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.

Also known as: Moses Laser Lithotripsy

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.

Also known as: Standard Laser Lithotripsy

Standard Laser Lithotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (6)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (11)

• 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.

  PMID: 27238615 BACKGROUND

• 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.

  PMID: 26344917 BACKGROUND

• 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.

  PMID: 30892062 BACKGROUND

• 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.

  PMID: 30614878 BACKGROUND

• 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.

  PMID: 29465749 BACKGROUND

• 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.

  PMID: 28340540 BACKGROUND

• 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.

  PMID: 29319478 BACKGROUND

• 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.

  PMID: 28914602 BACKGROUND

• Stern KL, Monga M. The Moses holmium system - time is money. Can J Urol. 2018 Jun;25(3):9313-9316.

  PMID: 29900818 BACKGROUND

• 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.

  PMID: 29253579 BACKGROUND

• Gelikman DG, Ibanez KR, Reed AM, Hsi RS, Nimmagadda N, Miller NL. Factors Affecting Holmium Laser Efficiency: Comparison of Laryngeal Mask Airway and Endotracheal Intubation During Ureteroscopy for Renal Stones. J Endourol. 2024 Jan;38(1):8-15. doi: 10.1089/end.2023.0294. Epub 2023 Dec 7.

  PMID: 37933898 DERIVED

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Miller, M.D.
• Organization: Vanderbilt University Medical Center - Department of Urology

nicole.miller@vumc.org

(615) 322-3807

Study Officials

• Nicole L Miller, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: January 13, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)