NCT01775488撤回不适用
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy device. The purpose of this study is to assess and monitor the performance of the Vortx Rx for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of BPH and eligible for endoscopic BPH surgery including Transurethral Resection of the Prostate [TURP], PVP, electrovaporization
- •Prostate volumes 30 - 80 gm based on transrectal ultrasound
- •Men ≥ 50 years of age
- •IPSS symptom score > 15 and IPSS bother score > 2
- •Baseline peak flow rate Qmax < 12 cc/s on two separate occasions with voided volume at least 150 cc
排除标准
- •History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine > 1.4)
- •Neurogenic bladder, Parkinson's disease
- •Prior treatment for urinary incontinence
- •Micturition frequency AND urgency. Micturition frequency defined as > 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // < 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs > 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?"
- •Intravesical prostate lobe protrusion > 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe
- •Active Urinary Tract Infection [UTI] (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)
- •PVR > 250 at time of enrollment or catheter dependent bladder drainage
- •History of chronic prostatitis within the last 5 years
- •Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment
- •History of known bleeding disorders (e.g. von Willebrand disease)
- •Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy [TUMT], TUNA, water induced thermotherapy, TURP, PVP)
- •Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA > 10 ng/mL. Men with free PSA < 25% and with PSA within an age and race-specific range may only be enrolled after a negative biopsy. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is deemed eligible to participate in the study.
- •Men interested in future fertility
- •Declines or unable to provide informed consent
- •Non-English-speaker
- •Life expectancy estimated to be less than one year
- •Unable or unwilling to complete all required questionnaires and follow-up assessments
- •In the opinion of the investigator, it is not in the subject's best interest to participate in the study.
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 6 months
* Record and report all adverse events. * Determine rate of occurrence of adverse events,serious adverse events and device-related adverse events as a measure of safety and as factors used to determine study success.
次要结局
- Assess initial prostate histotripsy treatment efficacy(Up to six months)
研究者
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