One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTindTM) in Subjects With Benign Prostatic Hypertrophy (BPH).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 8
- 主要终点
- IPSS
研究概览
简要总结
The study will include an implantation of the iTind device and 4 follow up visits up to 12 months after the implantation.
详细描述
After screening , eligible patients will undergo an an implantation procedure (operative), using the iTind device.
Implantation will be performed according to the Instructions For Use.
Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath, under direct vision. Before retrieval the subject will be asked for subjective discomfort evaluation and level of urgency in the past days after device insertion, about any AE and then the device will be retrieved.
The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months post implantation with an optional extension of follow up period (up to 36 months). In the visits the following will be assessed: Uroflow and residual urine volume tests, AE recording, IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects, in the local languages.
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 80 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 symptomatic BPH. IPSS symptom severity score above
- •Peak urinary flow of below 12 ml/sec
- •Prostate volume below 75 ml
- •Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
- •Subject that able to complete the study protocol.
- •Normal Urinalysis and urine culture
排除标准
- •cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
- •neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.;
- •a post void residual (PVR) volume above 250 ml measured by ultrasound or acute urinary retention
- •compromised renal function (i.e., serum creatinine level above 1.8 mg/dl, or upper tract disease);
- •confirmed or suspected bladder cancer;
- •recent (within 3 months) cystolithiasis or hematuria;
- •urethral strictures, bladder neck contracture, Urinary bladder stones
- •or other potentially confounding bladder pathology;
- •an active urinary tract infection.
- •Enrolled in another treatment trial for any disease within the past 30 days.
- •previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
- •previous pelvic irradiation or radical pelvic surgery;
- •previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- •Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
- •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.
结局指标
主要结局
IPSS
时间窗: 6 months.
Change of IPSS score by at least 3 points, in at least 75 % of the subjects, at 6 months follow-up. IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
SAE
时间窗: 5-7 days
The incidence of unexpected serious adverse events related to Meditate iTind and/or implantation/retrieval procedures, as determined by the investigator and the study medical monitor.
次要结局
- Urinary peak flow(12 months)