Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off
Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates. Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology. The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2023
CompletedFirst Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2026
ExpectedApril 30, 2026
July 1, 2025
2.9 years
March 22, 2024
April 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Operative time
Total amount of time (in minutes) taken to complete the procedure.
Day of procedure
Stone Free Rate
This is measured by KUB and Renal bladder ultrasound that is post-operative standard of care. Stone free is defined as no stone fragments seen on KUB or RBUS. If there are hyperechoic fragments seen on RBUS but not KUB and the stone analysis was not uric acid, the patient will be considered stone free. The investigators will also calculate a clinically stone free rate (\< 4mm residual fragments allowed). The Stone Free Rate assessments by the investigators will highlight the rate, or ratio of patients who are stone free and patients who are not stone free after procedure.
6-8 weeks post procedure
Secondary Outcomes (3)
Lasing time
Day of procedure
Total laser energy (kJ)
Day of procedure
Detection of postoperative strictures
12 weeks
Study Arms (2)
Moses 2.0 arm
ACTIVE COMPARATORUreteroscopy with high powered holmium laser lithotripsy with Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3x60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.3 J x 120 Hz (not to exceed 40 W)
Standard High-powered arm
ACTIVE COMPARATORUreteroscopy with high powered holmium laser lithotripsy without Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3 x 60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.5 J x 80 Hz standard (not to exceed 40 W)
Interventions
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments
Eligibility Criteria
You may qualify if:
- Undergoing ureteroscopy and laser lithotripsy
- Stone size ≥8 but \< 20 mm in the proximal ureter or kidney. Multiple stones ≤4 are allowed. Bilateral surgeries are allowed
- Willing to sign informed consent
You may not qualify if:
- Staged surgery
- Nephrocalcinosis
- Participant is less than 18 years of age
- Inability to provide informed consent
- Members of vulnerable patient populations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Ohio State Universitycollaborator
Study Sites (1)
Northwestern Medicine
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Krambeck, MD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology
Study Record Dates
First Submitted
March 22, 2024
First Posted
April 4, 2024
Study Start
June 9, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 9, 2026
Last Updated
April 30, 2026
Record last verified: 2025-07