Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off
NCT ID: NCT06346483
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-06-09
2026-06-09
Brief Summary
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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.
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Detailed Description
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8 to 12 weeks after surgery, participants will undergo a standard of care renal bladder ultrasound (RBUS) and Kidney Ureter Bladder Abdominal X-ray (KUB) to evaluate for stones and hydronephrosis, which is swelling of the kidney due to build-up of urine.
If there are abnormal findings on the RBUS or KUM at the 8 to 12 week follow-up, participants will be asked to return to the urology clinic and may have to repeat imaging to ensure participants did not develop a postoperative condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Moses 2.0 arm
Ureteroscopy 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)
Dusting with Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Moses 2.0 Modulation
Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments
Standard High-powered arm
Ureteroscopy 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)
Dusting without Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Interventions
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Dusting without Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Dusting with Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Moses 2.0 Modulation
Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Nephrocalcinosis
* Participant is less than 18 years of age
* Inability to provide informed consent
* Members of vulnerable patient populations
18 Years
90 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Northwestern University
OTHER
Responsible Party
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Amy Krambeck
Professor of Urology
Principal Investigators
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Amy Krambeck, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Alyssa McDonald
Role: primary
Other Identifiers
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STU00218929
Identifier Type: -
Identifier Source: org_study_id
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