Clinical trial NCT06346483: Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off
Official title: Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Ureteral Stone
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2024-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Day of procedure
measure: Stone Free Rate
timeFrame: 6-8 weeks post procedure
Secondary outcomes:
measure: Lasing time
timeFrame: Day of procedure
measure: Total laser energy (kJ)
timeFrame: Day of procedure
measure: Detection of postoperative strictures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Krambeck, MD
role: PRINCIPAL_INVESTIGATOR
References: