NCT05400980进行中（未招募）不适用
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
适应症
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
- 4
- 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).
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)
研究者
研究点 (4)
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