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

Last updated: July 1, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Stones

Treatment

Moses 2.0 Modulation

Dusting with Moses 2.0 Modulation

Dusting

Clinical Study ID

NCT06346483
STU00218929
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Undergoing ureteroscopy and laser lithotripsy

  • Stone size ≥8 but < 20 mm in the proximal ureter or kidney. Multiple stones ≤4 areallowed. Bilateral surgeries are allowed

  • Willing to sign informed consent

Exclusion

Exclusion Criteria:

  • Staged surgery

  • Nephrocalcinosis

  • Participant is less than 18 years of age

  • Inability to provide informed consent

  • Members of vulnerable patient populations

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: Moses 2.0 Modulation
Phase:
Study Start date:
June 09, 2023
Estimated Completion Date:
June 09, 2026

Study 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.

Connect with a study center

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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