NCT01436877已完成不适用
One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Device related and unanticipated SAE
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.
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 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject signed informed consent prior to the performance of any study procedures.
- •Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
- •IPSS symptom severity score ≥
- •Peak urinary flow of < 12 ml/sec
- •No pathology found with kidney US
- •Prostatic urethra length < 30 mm
- •Prostate volume < 35 cc
- •Normal Urinalysis and urine culture.
排除标准
- •Any prior prostate treatment
- •Suspected or proved carcinoma of prostate
- •Urethral stricture
- •Urinary bladder stones
- •Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy).
- •Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
- •Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
- •Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
- •Any serious medical condition likely to impede successful completion of the study
- •Intraoperative EC:
- •Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening
研究组 & 干预措施
device
Experimental
Insertion of Temporary Implantable Nitinol Device (TIND)
干预措施: Insertion of Temporary Implantable Nitinol Device (TIND) (Device)
结局指标
主要结局
Device related and unanticipated SAE
时间窗: At 3 months
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
次要结局
- Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects(At 3 months)
- Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects(At 3 months)
研究者
研究点 (1)
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