A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- AE rate
研究概览
简要总结
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI
详细描述
Study Objective:
To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.
Efficacy Endpoints:
The endpoints of this study are:
- Decrease in transition zone volume
- Monitor size and location of ablative lesions
- Monitor change in time of lesions
- Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
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
- 40 Years 至 —（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 40 and above- Male with symptomatic BPH.
- •IPSS symptom severity score ≥ 13
- •Peak urinary flow of < 12 ml/sec
- •Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
- •Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
- •Subject able to comply with the study protocol
- •Normal urinalysis and negative urine culture
- •Subjects that are able to undergo MRI.
排除标准
- •A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
- •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
- •Median lobe obstruction of the prostate (larger than 1cm).
- •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)
- •Patient with renal dysfunction
- •Any serious medical condition likely to impede successful completion of the study
结局指标
主要结局
AE rate
时间窗: 12 months
Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
Unexpected SAE
时间窗: 12 months
Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.
Device complications
时间窗: 12 months
Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications
次要结局
未报告次要终点