Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern Medicine
RECRUITING
Chicago
Contact Information
Primary
Alyssa McDonald, MPH
alyssa.mcdonald@northwestern.edu
312-695-8146
Backup
Allaa Fadl-Alla, BS
allaa.fadlalla@northwestern.edu
312-695-8146
Time Frame
Start Date: 2023-06-09
Estimated Completion Date: 2026-06-09
Participants
Target number of participants: 150
Treatments
Active_comparator: 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)
Active_comparator: 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)
Sponsors
Leads: Northwestern University
Collaborators: Ohio State University

This content was sourced from clinicaltrials.gov