Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The primary outcome is vaporization efficiency, measured in g/min
研究概览
简要总结
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization.
详细描述
Patients will be evaluated preoperatively per standard of care in urology clinic. We will obtain American Urological Association Symptom Score (AUA-SS) and Quality of Life (QoL) assessment as well as post-void residual bladder scan (PVR), and prostate specific antigen (PSA). All of these assessments will be part of standard of care.
Based on the current coronavirus (COVID-19) pandemic and the changing health landscape with increased emphasis on telehealth, patient may be offered virtual appointments for aspects of the trial that do not require in-person evaluation or testing. These include but are not limited to inclusion/exclusion criteria evaluation, consent for trial participation, or survey completion.
Patients will be taken to the operating room per standard of care. They will be randomized to either Holmium Laser Vaporization of Prostate (HoLVP) with or without the use of Moses 2.0 technology. The surgeon and patient will both be blinded to the laser mode.
HoLVP will occur in standard fashion thereafter utilizing at 550-micron holmium Xpeeda side fire laser fiber at settings of 2 Joules, 50 Hertz. Moses 2.0 will be activated or not by operating room personnel based on patient's randomization status. Again, the surgeon and assistant will not be informed of the Moses status.
Intraoperative parameters will be recorded including total procedure time, total vaporization time, vaporization efficiency (g/min), and total energy used. Surgeons will evaluate tissue char, visibility, hemostasis, as well as select if they think Moses 2.0 was activated or not for the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Patients with bothersome lower urinary tract symptoms who opt for surgical management
- •Prostate size 60g or less
排除标准
- •Current use of anticoagulation or antiplatelet agent Aspirin 81 use is okay and can be continued through the study
- •Bleeding diathesis
- •AUA symptom score < 9
- •Current urinary retention
- •Known diagnosis of prostate cancer
- •Known diagnosis of neurogenic bladder
结局指标
主要结局
The primary outcome is vaporization efficiency, measured in g/min
时间窗: 5 years
The primary outcome is vaporization efficiency, measured in g/min. For the purposes of this study, we defined improvement as at least a 50% improvement in ablation efficiency, based on improvements in enucleation efficiency observed in a recent study . Furthermore, based on a previous study we made of Moses 1.0, the ablation efficiency of Moses 1.0 is 1.77 g/min with a standard deviation of 1.41 g/min.7 Differences in ablation efficiency will be tested via Welch's t-test.10 Therefore, we calculated the sample size based on an anticipated improvement of efficiency to at least 2.66 g/min. We further allowed for a somewhat higher standard deviation for Moses 2.0 at 2 g/min, as the variance tends to increase as the efficiency increases. This resulted in an anticipated standardized effect size of approximately 0.51 standard deviations (moderate effect). At a significance level of 0.05 and 80% power, this means we will need 62 subjects per arm in the study.
次要结局
- Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale(5 years)
研究者
Don Neff, MD, FACS
Associate Professor
University of Kansas Medical Center