SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP
研究概览
简要总结
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.
Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations
详细描述
Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 must be 18 years of age or older
- •Patients must be diagnosed with benign prostatic hyperplasia
- •Patients must opt for surgical management of their BPH with laser enucleation
排除标准
- •Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- •Patients with prostate glands greater or equal to 200 grams
- •Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
结局指标
主要结局
Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP
时间窗: up to 1 year
To evaluate SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) in comparison to Holmium Laser Enucleation of the Prostate through AUA Symptom Score. AUA Symptom score will be assessed using the Scale - Mild (under 7 cumulative score, moderate 8-19 score, and severe is a cumulative score over 20).
次要结局
- Compare intraoperative components between the two surgical approaches(up to 1 year)
- Compare post-operative outcomes of the two surgical approaches(up to 2 years)
研究者
Don Neff, MD, FACS
Principle Investigator
University of Kansas Medical Center