Kidney Stone, Ureteral Stone
Conditions
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.
Interventions
PROCEDUREDusting 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.
PROCEDUREDusting 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.
OTHERMoses 2.0 Modulation
Lumenis Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology used for lithotripsy and BPH treatments
Sponsors
Northwestern University
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Day of procedure | Total amount of time (in minutes) taken to complete the procedure. |
| Stone Free Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Lasing time | Day of procedure | (no residents, fellows will be allowed under attending supervision) |
| Total laser energy (kJ) | Day of procedure | The energy setting of the laser that is used during procedure. |
| Detection of postoperative strictures | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Krambeck, MD
Northwestern University
Outcome results
None listed