NCT03239652Unknown不适用
Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Patients Survival (Safety)
研究概览
简要总结
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
详细描述
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A. Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.
- •B. Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS.
- •C. Prostate volume > 50 mL.
- •D. Urinary flow rate <15 mL / sec.
- •E. Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate.
排除标准
- •If patients meet any of the following criteria they may not be entered into the study:
- •A. Major pelvic disease, or other malignancies.
- •B. Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL).
- •C. Had Prostate surgery.
- •D. Chronic bacterial prostatitis.
- •E. Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.
- •F. Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
- •G. White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable .
- •H. Unable to follow-up by MRI 3 times.
- •I. Unable to follow-up by ultrasound or CT scan.
- •J. Unwilling to sign a written informed consent form.
- •K. Allergic to Iodine or other injections.
- •L. Acute bacterial prostatitis.
- •M. Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis.
- •N. Cases of biopsy proven prostate, bladder, or urethral cancer.
- •O. Patients with glomerular filtration rates less than 40 who are not already on dialysis.
- •P. Patients with bilateral internal iliac arterial occlusion.
- •Q. Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc).
- •R. Patients with neurogenic or bladder atonia.
- •S. Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue.
- •T. Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
- •U. Patients with urethral stents.
- •V. Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery.
- •W. Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization.
- •X. Allergic to pharmaceutical excipients related to Microspheres.
研究组 & 干预措施
Taiwan ACE Beads microspheres
Experimental
The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.
干预措施: Taiwan ACE Beads (Device)
结局指标
主要结局
Patients Survival (Safety)
时间窗: An average of 12 weeks.
Survival rate was evaluated since treatment day until the date of death or final observation.
次要结局
- Change in serum Prostate Specific Antigen (PSA) concentration(Before treatment, one and three months after treatment.)
- Change on Prostate Volume(Before treatment, one and three months after treatment.)
- Change on Patient's Symptoms(Before treatment, one and three months after treatment)
研究者
研究点 (1)
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