A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Freedom from Unanticipated adverse device effects (UADEs)
研究概览
简要总结
To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.
详细描述
A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male gender
- •Age ≥ 50 years
- •Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
- •Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound).
- •Medication history
- •Not on BPH related medication for the past 6 months.
- •If on BPH related medication:
- •On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern
- •On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern
- •Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS):
- •With International Prostate Symptom Score (IPSS) > 13; Qmax < 12 mL/sec on a voided volume ≥125 mL; Post-void residual (PVR) < 250 mL; QoL score ≥ 3
排除标准
- •Previous BPH procedure
- •Median prostatic lobe or high bladder neck
- •Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- •Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
- •Cystolithiasis within the prior 3 months
- •History of neurogenic bladder or urinary retention with PVR >1000mL.
- •Serum creatinine >1.8 mg/dl or upper-tract disease which compromises renal function
- •Current or recent Urinary Tract Infection (UTI) or disease
- •Known allergy to nickel
- •Life expectancy of less than 24 months
- •Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
- •Anticipated need for additional surgery or treatments for comorbidities during the study period.
- •Current gross hematuria
- •Other co-morbidities that could impact the study results
- •Unable or unwilling to complete all required questionnaires and follow-up assessments
- •Unable or unwilling to sign informed consent form
- •Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
研究组 & 干预措施
Arm-1: Device implantation for 1 month
Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.
干预措施: XFLO Expander System (Device)
Arm-2: Device implantation for 6 months
Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.
干预措施: XFLO Expander System (Device)
Arm-3: Device implantation for 12 months
Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.
干预措施: XFLO Expander System (Device)
结局指标
主要结局
Freedom from Unanticipated adverse device effects (UADEs)
时间窗: 6 months (Arm-2)
Measure any device or procedure related adverse events
Freedom from Unanticipated adverse device effects (UADEs)
时间窗: 1 month (Arm-1)
Measure any device or procedure related adverse events
次要结局
- Freedom from Unanticipated adverse device effects (UADEs)(12 months (Arm-2))
- Change in International Prostate Symptom Score (IPSS)(6 and 12 months (Arm-2))
- Freedom from Unanticipated adverse device effects (UADEs)(7 months (Arm-1))
- Change in International Prostate Symptom Score (IPSS)(1 month and 7 months (Arm-1))