NCT02506465已完成不适用
Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (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
- 185
- 试验地点
- 13
- 主要终点
- Month 3 Results in the IPSS Score in Both Arms.
研究概览
简要总结
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
详细描述
Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH.
A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria.
Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.
iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 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 form (ICF)
- •Age 50 and above
- •Male with symptomatic BPH.
- •IPSS symptom severity score ≥ 10
- •Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
- •Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
- •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 able to comply with 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
- •A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
- •Compromised renal function (i.e., serum creatinine level > 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 colo- 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, cryosurgery or radical pelvic surgery;
- •Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- •History of prostatitis within the past 5 years.
- •Median lobe obstruction of 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).
- •Any serious medical condition likely to impede successful completion of the study
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
- •Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
- •Baseline PSA ≥ 10 ng/ml.
- •Positive DRE.
- •Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.
研究组 & 干预措施
Sham arm
Sham Comparator
Foley catheter is used during the study
干预措施: Sham Arm (Procedure)
iTind arm
Experimental
iTind implant is implant during the study for 5-7 days.
干预措施: iTIND (Device)
结局指标
主要结局
Month 3 Results in the IPSS Score in Both Arms.
时间窗: 3 months
Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
次要结局
- Qmax Measurement(3 months)
- PVR(3 months)
- IIEF Questionnaire(3 months)
- SHIM(3 months)
研究者
研究点 (13)
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