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Laser Lithotripsy for Kidney Stones
Chicago, IL
N/A
Recruiting
Led By Amy Krambeck, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the effectiveness of Moses 2.0 pulse modulation technology with the standard high powered Holmium Laser lithotripsy in treating kidney and ureteral stones. The study will
See full description
Who is the study for?
This trial is for individuals with kidney or ureteral stones measuring between 6mm and less than 20mm, who are undergoing a procedure called ureteroscopy. The study aims to include those who require stone removal using laser technology.
What is being tested?
The study compares two methods of breaking down kidney stones: the Moses 2.0 pulse modulation technology versus the standard high-powered Holmium Laser without this feature. It will assess which method is more efficient in terms of operating time, laser usage, energy required, and success in eliminating stones.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, typical risks associated with laser lithotripsy may include discomfort during urination, bleeding around the stone fragments, infection risk from the procedure itself or passing stone fragments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Operative time
Stone Free Rate
Secondary study objectives
Detection of postoperative strictures
Lasing time
Total laser energy (kJ)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Standard High-powered armActive Control1 Intervention
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)
Group II: Moses 2.0 armActive Control2 Interventions
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)
Find a Location
Closest Location:Northwestern Medicine· Chicago, IL
Who is running the clinical trial?
Ohio State UniversityOTHER
888 Previous Clinical Trials
2,661,664 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,670 Previous Clinical Trials
987,696 Total Patients Enrolled
Amy Krambeck, MDPrincipal InvestigatorNorthwestern University
3 Previous Clinical Trials
548 Total Patients Enrolled