An Open Label, Single Center, Pilot Study to Evaluate the Safety and Effectiveness of OCL 503 in Prostate Artery Embolization for the Treatment of Men With Benign Prostatic Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety of OCL 503 as measured by Adverse Events reporting.
研究概览
简要总结
This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.
详细描述
Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, IPSS, uroflowmetry, IIEF, and MRI pelvic imaging. Following conventional catheter angiography with cone-beam CT to confirm catheter placement and prostatic vasculature, each patient will undergo transarterial embolization with OCL 503. OCL 503 will be administered intra-arterially via microcatheter until there is stasis of blood flow.
Patient assessments include blood work, IPSS, uroflowmetry, IIEF, MRI and patient interviews conducted at 3 months, 6 months, and 12 months post embolization.
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
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
- •Patient is greater than 50 years of age
- •Patient has had a pelvic examination within the past 6 months
- •Patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy
- •Patient has a Qmax below 15 mL/s or acute urinary retention
- •Prostate is larger than 40 cubic centimetres
- •Patient is willing and able to provide written, informed consent
排除标准
- •Known malignancy
- •Serum PSA > 10 ng/mL at screening
- •Advanced atherosclerosis and tortuosity of the iliac arteries
- •Prior transurethral resection of the prostate (TURP)
- •Post void retention (PVR) > 250 mL
- •Chronic use of metronidizole
- •Phytotherapy for BPH within last two weeks of screening visit
- •Secondary renal insufficiency due to prostatic obstruction
- •Chronic renal failure (GSR < 60)
- •Large bladder diverticula or bladder stones
- •Claustrophobia or other contraindications related to performing MRI
- •Compromised hematopoietic function
- •Anaphylactic reaction to drug or anesthetic, allergic reaction to iodine or contrast media
- •Investigational drug or experimental therapy in the past 4 weeks
- •Abnormal coagulation profile
- •Allergy to bovine collagen
研究组 & 干预措施
Prostate Artery Embolization
Transarterial administration of OCL 503 to the arteries feeding the prostate.
干预措施: Prostate artery embolization. (Device)
结局指标
主要结局
Safety of OCL 503 as measured by Adverse Events reporting.
时间窗: 12 months
Measurement of device related adverse events post embolization of the prostatic vasculature, at 30 days.
International Prostate Symptom Score (IPSS)
时间窗: 12 months
Measurement of IPSS at 12 months post embolization of the prostatic vasculature with OCL 503.
次要结局
- International Index of Erectile Function (IIEF)(12 months)
- Uroflowmetry(12 months)
- Tissue Response(12 months)