← Back to Search

Procedure

Holmium vs Thulium Lasers for Kidney Stones

Q: How many medical institutions are managing this research?

<p>This trial is being conducted at Glickman Urological &#x26; Kidney Institute in Cleveland, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>; Mount Sinai Health System in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, New York; and Wexner Medical Center in Columbus, <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> as well as 5 additional sites.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months post-op (up to 10 weeks on study)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I need outpatient laser treatment for my kidney stones.

Select...

My kidney stone is between 5mm and 20mm in size.

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)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stone Free Rate

Secondary outcome measures

Laser Efficiency in millimeters per minute

Number of Participants with Procedural Complications

Participant Quality of Life as Measured by the WISQOL Short Form Score

+4 more

Trial Design

2Treatment groups

Active Control

Group I: Thulium fiber laserActive Control1 Intervention

Group II: Holmium laser with pulse modulationActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,077 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

192 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons below the age of 55 permissible to join this trial?

"Eligibility criteria for this clinical trial stipulate that participants should be no younger than 18 and not exceed the age of 89."

Answered by AI

What eligibility criteria must potential participants meet in order to join this medical research?

"Patients with kidney stones who are between 18 and 89 years old can apply to join this medical study. The research team is seeking to recruit approximately 310 eligible participants."

Answered by AI

How many individuals have registered to participate in this clinical trial?

"In order to execute the trial, we seek 310 eligible individuals. Trials are occurring across numerous sites such as Glickman Urological & Kidney Institute in Cleveland, Ohio and Mount Sinai Health System in New york City."

Answered by AI

Is there still capacity for patients to join this experiment?

"Affirmative, the information held on clinicaltrials.gov provides evidence that this research is presently searching for test subjects. This investigation was launched on September 7th 2023 and its most recent amendment occurred October 2nd 2023; it is looking to recruit a total of 310 individuals from 5 sites."

Answered by AI

How many medical institutions are managing this research?

"This trial is being conducted at Glickman Urological & Kidney Institute in Cleveland, Ohio; Mount Sinai Health System in New york, New York; and Wexner Medical Center in Columbus, Wisconsin as well as 5 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

2023. "Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06070714.

All > Kidney Stone > Madison