Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off

April 26, 2026 updated by: Amy Krambeck, Northwestern University

Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation

The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.

Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.

The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high powered laser dusting with Moses 2.0 pulse modulation and the dust produced will pass spontaneously through the urine. The other group will have stones treated with standard of care high power laser fragmentation and the dust produced will pass spontaneously through the urine. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study.

8 to 12 weeks after surgery, participants will undergo a standard of care renal bladder ultrasound (RBUS) and Kidney Ureter Bladder Abdominal X-ray (KUB) to evaluate for stones and hydronephrosis, which is swelling of the kidney due to build-up of urine.

If there are abnormal findings on the RBUS or KUM at the 8 to 12 week follow-up, participants will be asked to return to the urology clinic and may have to repeat imaging to ensure participants did not develop a postoperative condition.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing ureteroscopy and laser lithotripsy
  • Stone size ≥8 but < 20 mm in the proximal ureter or kidney. Multiple stones ≤4 are allowed. Bilateral surgeries are allowed
  • Willing to sign informed consent

Exclusion Criteria:

  • Staged surgery
  • Nephrocalcinosis
  • Participant is less than 18 years of age
  • Inability to provide informed consent
  • Members of vulnerable patient populations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moses 2.0 arm

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)
Procedure: Dusting with Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Other: Moses 2.0 Modulation
Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments
Active Comparator: Standard High-powered arm

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)
Procedure: Dusting without Moses 2.0 Modulation
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Day of procedure
Total amount of time (in minutes) taken to complete the procedure.
Day of procedure
Stone Free Rate
Time Frame: 6-8 weeks post procedure

This is measured by KUB and Renal bladder ultrasound that is post-operative standard of care.

Stone free is defined as no stone fragments seen on KUB or RBUS. If there are hyperechoic fragments seen on RBUS but not KUB and the stone analysis was not uric acid, the patient will be considered stone free. The investigators will also calculate a clinically stone free rate (< 4mm residual fragments allowed).

The Stone Free Rate assessments by the investigators will highlight the rate, or ratio of patients who are stone free and patients who are not stone free after procedure.
6-8 weeks post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lasing time
Time Frame: Day of procedure
(no residents, fellows will be allowed under attending supervision)
Day of procedure
Total laser energy (kJ)
Time Frame: Day of procedure
The energy setting of the laser that is used during procedure.
Day of procedure
Detection of postoperative strictures
Time Frame: 12 weeks
If postoperative ultrasound shows hydronephrosis at follow up. Repeat Ultrasound will be obtained 1 month later. If hydronephrosis persists, CT urogram will be obtained. If stricture is identified, then appropriate intervention will be recommended.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Amy Krambeck, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 9, 2026

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00218929

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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