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Laser Lithotripsy for Kidney Stones

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

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of procedure for reporting.

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)

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