Comparison of Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Without Moses 2.0 Pulse Modulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Staged surgery
- •Nephrocalcinosis
- •Participant is less than 18 years of age
- •Inability to provide informed consent
- •Members of vulnerable patient populations
研究组 & 干预措施
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)
干预措施: Dusting with Moses 2.0 Modulation (Procedure)
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)
干预措施: Moses 2.0 Modulation (Other)
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)
干预措施: Dusting without Moses 2.0 Modulation (Procedure)
结局指标
主要结局
Operative time
时间窗: Day of procedure
Total amount of time (in minutes) taken to complete the procedure.
Stone Free Rate
时间窗: 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.
次要结局
- Lasing time(Day of procedure)
- Detection of postoperative strictures(12 weeks)
- Total laser energy (kJ)(Day of procedure)
研究者
Amy Krambeck
Professor of Urology
Northwestern University