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Procedure
Holmium vs Thulium Lasers for Kidney Stones
N/A
Waitlist Available
Led By Stephen Nakada, MD, FACS, FRCS
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with renal stones who require endoscopic laser treatment in the outpatient operating room
Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm
Must not have
Patients with known ureteral stricture disease
Patients with irreversible coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months post-op (up to 10 weeks on study)
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two laser systems to treat kidney stones during a procedure. 310 people will be involved at 5 sites.
Who is the study for?
This trial is for patients with kidney stones sized between 5mm and 20mm who need laser treatment. It's not for pregnant individuals, those with transplant kidneys or certain anatomical variations, irreversible coagulopathy, ureteral strictures, non-English speakers without decision-making capacity, recent prior treatments, urothelial tumors, or specific metabolic conditions.
What is being tested?
The study compares two types of lasers in breaking down kidney stones during surgery: the Lumenis® Pulse™ P120H holmium laser system using Moses technology versus the Soltive™ SuperPulsed Laser System with thulium fiber laser. Participants are randomly assigned to one of these treatments at five different research sites.
What are the potential side effects?
Potential side effects may include discomfort from the procedure itself such as pain or bleeding; risks associated with any surgical intervention like infection; and specific reactions to each type of laser which will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need outpatient laser treatment for my kidney stones.
Select...
My kidney stone is between 5mm and 20mm in size.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known narrowing of my ureters.
Select...
I have a permanent blood clotting disorder.
Select...
I have a unique kidney condition or have had a kidney transplant.
Select...
My condition involves a bladder tumor and unsuccessful attempts to remove kidney stones without using lasers.
Select...
I have a kidney condition, either renal tubular acidosis or medullary sponge kidney.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months post-op (up to 10 weeks on study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months post-op (up to 10 weeks on study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stone Free Rate
Secondary study objectives
Participant Quality of Life as Measured by the WISQOL Short Form Score
Procedural time
Stone Treatment Time in Minutes
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: Thulium fiber laserActive Control1 Intervention
Group II: Holmium laser with pulse modulationActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,669 Total Patients Enrolled
3 Trials studying Kidney Stones
3,370 Patients Enrolled for Kidney Stones
Stephen Nakada, MD, FACS, FRCSPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
272 Total Patients Enrolled