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Laser Lithotripsy

Holmium laser with thulium lasers for Kidney Stones

Phase 4
Waitlist Available
Led By Stephen Nakada, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two laser treatments, Holmium with Moses and thulium, for breaking up kidney stones. It aims to find out which one is faster and more effective, potentially reducing surgery time and complications. The thulium fiber laser (TFL) is an emerging technology that has shown higher efficiency in breaking stones compared to the conventional holmium:YAG laser.

Eligible Conditions
  • Kidney Stones

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline(pre-operative) and approximately 8 weeks (1 month post-operative)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline(pre-operative) and approximately 8 weeks (1 month post-operative) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedural Time (Minutes)
Secondary study objectives
Ablation Efficiency (J/mm^3)
Ablation Speed
Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively
+4 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants treated with Holmium laser with the thulium laserExperimental Treatment1 Intervention
Group II: Participants treated with Holmium laser with the Moses laserExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Holmium laser with thulium lasers
2021
Completed Phase 4
~120
Holmium laser with Moses lasers
2021
Completed Phase 4
~120

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,230 Previous Clinical Trials
3,199,711 Total Patients Enrolled
4 Trials studying Kidney Stones
3,680 Patients Enrolled for Kidney Stones
Stephen Nakada, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
257 Total Patients Enrolled
1 Trials studying Kidney Stones
40 Patients Enrolled for Kidney Stones
~26 spots leftby Nov 2025
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