Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ablation Time
研究概览
简要总结
Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device. Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure.
The primary objective of this study is to explore Vaporization efficacy and safety when treating BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subject will be older than 18 years of age
- •Subject was diagnosed with enlarged prostate of ≥ 30 gr volume
- •Subject is a candidate for surgery treatment
- •Subject is willing and has signed the Informed Consent Form
- •AUA score ≥ 12
- •Qmax <15 mL/s
排除标准
- •Need to perform concomitant procedure, other than prostate vaporization
- •PVR > 300 mL
- •Current Urine retention and Pdet <40 cm H20
- •Documented or suspected prostate cancer and / or bladder cancer
- •Neurogenic bladder disorder / neurogenic voiding dysfunction
- •Urethral strictures
- •Previous prostatic, bladder neck, or urethral surgery
- •Known history of spinal cord injury
- •Urogenital trauma
- •Bladder neck stricture
- •Evidence of urinary tract infection
- •History of chronic prostatitis
结局指标
主要结局
Ablation Time
时间窗: Intraprocedural (procedure time is typically 1 to 3 hours)
Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.
Ablation Rate
时间窗: Baseline and 3-month follow-up visit
Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time. Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes
Efficiency of the Laser to Ablate the Prostate
时间窗: Baseline and 3-month follow-up visit
Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy. Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J
Safety: Intraoperative Complications
时间窗: Intraoperative (procedure time is typically 1 to 3 hours)
Number and type of intraoperative complications
Safety: Perioperative Complications
时间窗: Post-procedure through 3 months
Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia
次要结局
- Erectile Dysfunction(Baseline and 3-month follow-up visit)
- Visibility During Procedure(Intraprocedural (procedure time is typically 1 to 3 hours))
- Number of Fibers Used During Procedure(Intraprocedural (procedure time is typically 1 to 3 hours))
- Catheterization Time(Postoperatively through study completion up to 3 months)
- Hospital Stay Duration(Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months))
- International Prostate Symptom Score Quality of Life(Baseline, 1-month and 3-month follow-up visits)
- Qmax Uroflow(Baseline, 1-month and 3-month follow-up visits)
- PVR (Post-void Residual)(Baseline, 1-month and 3-month follow-up visits)
- PSA (Prostate-specific Antigen)(Baseline and 3-month follow-up visit)
- Americal Urological Association (AUA) Symptom Index(Baseline, 1-month and 3-month follow-up visits)