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

NCT ID: NCT06346483

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2026-06-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Stone Ureteral Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Dusting with Moses 2.0 Modulation

Intervention Type PROCEDURE

Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Moses 2.0 Modulation

Intervention Type OTHER

Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments

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)

Group Type ACTIVE_COMPARATOR

Dusting without Moses 2.0 Modulation

Intervention Type PROCEDURE

Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Moses 2.0 Modulation

Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Krambeck

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Krambeck, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alyssa McDonald, MPH

Role: CONTACT

312-695-8146

Allaa Fadl-Alla, BS

Role: CONTACT

312-695-8146

Facility Contacts

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Alyssa McDonald

Role: primary

Other Identifiers

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STU00218929

Identifier Type: -

Identifier Source: org_study_id

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