NCT07640776尚未招募不适用
Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
详细描述
This study will be a prospective, non-randomized study in 40 subjects at up to five clinical sites in the United States. A total of 40 subjects will be treated with IRE and followed for evaluation of primary and secondary endpoints at 6 months post-treatment. Long-term follow-up will continue through 5 years post-treatment for secondary endpoints.
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
- •Male, age ≥50 years.
- •Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH).
- •International Prostate Symptom Score (IPSS) ≥13 at screening.
- •Peak urinary flow rate (Qmax) ≤12 mL/sec on non-catheterized free flow with voided volume ≥125 mL.
- •Post-void residual (PVR) ≤250 mL.
- •Prostate volume between 30 cc and 80 cc by transrectal ultrasound (TRUS) or Magnetic Resonance Imaging (MRI).
- •Willing and able to comply with all study procedures and follow-up requirements.
- •Able to provide written informed consent.
- •Life expectancy ≥10 years.
排除标准
- •Patients with ≥ Grade Group 2 prostate cancer (≥ Gleason score 7).
- •Patients with Grade Group 1 prostate cancer (Gleason score 6) on active surveillance for less than 1 year.
- •Patients with PSA ≥10 ng/mL or PSA density ≥0.15 ng/mL
- •Prior surgical or minimally invasive intervention for BPH (e.g., TURP, Rezūm™, UroLift®, laser therapy).
- •Presence of urethral stricture or bladder neck contracture.
- •Patients with a history of pelvic radiation/irradiation.
- •Patients with compromised renal function (serum creatinine level >1.8 mg/dL or upper-tract disease).
- •Obstructing median lobe intravesical prostatic protrusion (IPP) with >1 cm assessed by TRUS or MRI.
- •Active urinary tract infection, prostatitis, or gross hematuria within 3 months of enrollment.
- •Active need of catheterization.
- •Known or suspected neurogenic bladder or underlying neurologic disease affecting bladder function (e.g., Parkinson's disease, multiple sclerosis, stroke with residual urinary symptoms).
- •History of bladder cancer or other urological malignancy.
- •Implanted electrical devices (e.g., pacemaker, defibrillator, neurostimulator) incompatible with IRE energy delivery.
- •Uncorrected bleeding diathesis or current therapeutic anticoagulation that cannot be safely interrupted.
- •Current use of BPH medications unless on a stable dose for ≥6 weeks (alpha-blockers, anticholinergics, beta-3 adrenergic agonists) or ≥6 months (5-alpha reductase inhibitors, phosphodiesterase type 5 inhibitors) prior to baseline, with no planned changes during study follow-up.
- •Prior rectal or pelvic surgery that may interfere with treatment delivery or evaluation.
- •Desire to preserve future fertility.
- •Severe or uncontrolled comorbidities (e.g., NYHA class III/IV heart failure, uncontrolled diabetes, severe pulmonary disease) that, in the opinion of the investigator, would increase study risk or confound outcomes.
- •Participation in another clinical trial involving an investigational drug or device within 30 days prior to enrollment.
- •Patients who are members of a vulnerable population, such as the cognitively challenged or incarcerated, that could expose them to undue influence, coercion, or inability to provide informed consent.
研究者
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