The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® Expander System and Retrieval Sheath
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Safety of Urocross Expander Implant
研究概览
简要总结
To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).
详细描述
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
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
- Double (Participant, Outcomes Assessor)
盲法说明
All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has signed an informed consent form (ICF).
- •Men ≥ 45 years.
- •Symptomatic BPH with the following (all must be met):
- •Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL.
- •PVR < 250 mL.
- •Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
- •Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation.
- •Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.
排除标准
- •Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
- •Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
- •Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
- •High bladder neck as determined by the Investigator.
- •Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
- •Biopsy of the prostate within past 8 weeks.
- •Baseline Prostate Specific Antigen (PSA) level > 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level > 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making [SDM] with the study subjects).
- •Confirmed or suspected bladder cancer.
- •History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
- •History of neurogenic bladder.
- •Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
- •Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
- •Serum creatinine > 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).
- •Concomitant UTI (subject can be enrolled following successful treatment of UTI and a negative UTI test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).
- •Active infection including acute bacterial prostatitis.
- •Previous pelvic irradiation or radical pelvic surgery.
- •Known allergy to nickel.
- •Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
- •Desire to maintain fertility post-treatment.
- •Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
- •Prostatic urethral length < 25 mm or > 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
- •Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:
- •severe cardiac arrhythmias uncontrolled by medications or pacemaker.
- •congestive heart failure New York Heart Association (NYHA) III or IV.
- •uncontrolled diabetes mellitus.
- •significant respiratory disease in which hospitalization may be required.
- •known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy).
- •Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.
- •Note: Low dose aspirin therapy is acceptable.
- •Unable or unwilling to complete all required questionnaires and follow-up assessments.
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
- •Subject is in custody or institution, or, in the Investigator's opinion, has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).
研究组 & 干预措施
Sham-control group
The sham-control in this trial is cystoscopy only.
干预措施: Sham-control (Diagnostic Test)
Urocross implant group
The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.
干预措施: Urocross implant (Device)
结局指标
主要结局
Safety of Urocross Expander Implant
时间窗: more than 7 days post procedure
The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.
Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath
时间窗: 3 months post-procedure
The primary efficacy endpoint is Change from Baseline in Total International Prostate Symptom Score (IPSS) at 3 months post-procedure. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms. The study is powered to show that the average improvement in Total IPSS among the Urocross Implant subjects is more than 25% greater than the average improvement in Total IPSS among the sham-control subjects.
次要结局
- Percent change in Total IPSS for subjects randomized to the Urocross Implant(3 months post-procedure)