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NCT Number: NCT06346483

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

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.

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Key information

Conditions

Kidney Stone Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Diseases Ureteral Stone Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dusting without Moses 2.0 Modulation

Procedure

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

Dusting with Moses 2.0 Modulation

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

Other

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

Primary outcomes

  1. Operative time

    Time frame: Day of procedure

    Total amount of time (in minutes) taken to complete the procedure.

  2. 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.

Secondary outcomes

  1. Lasing time

    Time frame: Day of procedure

    (no residents, fellows will be allowed under attending supervision)

  2. Total laser energy (kJ)

    Time frame: Day of procedure

    The energy setting of the laser that is used during procedure.

  3. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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