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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 below
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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.
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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 weeks
Treatment ~ Varies
Follow Up ~2 months post-op (up to 10 weeks on study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months post-op (up to 10 weeks on study) for reporting.

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
1,230 Previous Clinical Trials
3,199,515 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
~21 spots leftby Dec 2024
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