Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off
Purpose
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.
Conditions
- Kidney Stone
- Ureteral Stone
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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) |
|
|
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) |
|
Recruiting Locations
Chicago, Illinois 60611
Alyssa McDonald
More Details
- NCT ID
- NCT06346483
- Status
- Recruiting
- Sponsor
- Northwestern University
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.