Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of patients with treatment related adverse events assessed by CTCAE v4.0.
研究概览
简要总结
This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.
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
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years and ≤ 85 years old
- •Prostate volume ≥ 40 mL and ≤ 300 mL
- •Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
- •Refractory or intolerant to medical management
- •Ineligibility for or refusal of surgical management
- •No evidence of prostate cancer
排除标准
- •History of pelvic cancer
- •Neurogenic bladder disorder
- •Bladder diverticula greater than 5 cm or bladder stones
- •Acute urinary retention with Foley catheter dependence
- •Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
- •Prior surgical prostate intervention
- •Active participation in another clinical trial
研究组 & 干预措施
Balloon occlusion microcatheter
Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.
干预措施: Prostatic artery embolization (Device)
Standard microcatheter
Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.
干预措施: Prostatic artery embolization (Device)
结局指标
主要结局
Number of patients with treatment related adverse events assessed by CTCAE v4.0.
时间窗: 12 months post PAE
Mean change from baseline in symptom score using the IPSS scale at 6 months
时间窗: Baseline and 6 months post PAE
次要结局
- Mean change from baseline in Qmax (maximum urinary flow)(Baseline, 6 months and 12 months post PAE)
- Mean change from baseline in prostate volume(Baseline, 6 months and 12 months post PAE)
- Mean change from baseline in IPSS to measure long-terms subjective outcome(Baseline, 12 and 24 months post PAE)
- Mean change from baseline in PVR (post void residual)(Baseline, 6 months and 12 months post PAE)
研究者
Andrew Picel
Assistant Clinical Professor
Stanford University