NCT06965582Enrolling By Invitation不适用
A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia
ALPFA Medical6 个研究点 分布在 3 个国家目标入组 100 人开始时间: 2025年2月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Primary Safety Outcome
研究概览
简要总结
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH.
Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who are ≥ 45 years of age on the day of enrollment.
- •Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
- •Life expectancy: the patient has a life expectancy of ≥ 1 year
- •Patient participation: The patient
- •is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements.
- •is willing and capable of providing Informed Consent to undergo study procedures.
- •agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study.
- •lives close enough to the investigational site to facilitate the required in-person visits.
排除标准
- •Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- •Previous operative intervention for BPH
- •Active urinary tract infection (may be treated and enrolled upon negative urine culture).
- •Prostatitis: a history of any prostatitis within 2 years of enrollment.
- •Cystolithiasis active within 90 days of enrollment
- •artificial sphincters.
- •Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer
- •Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- •a. Unstable cardiovascular disease including: i. NYHA III/IV heart failure or LVEF < 40% ii. Uncontrolled arrhythmia iii. Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment iv. Uncontrolled hypertension b. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy.
- •c. Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis. d. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant e. Active substance abuse: active alcoholism or
研究组 & 干预措施
Treatment Arm
Experimental
干预措施: ALPFA BPH PFA System (Device)
结局指标
主要结局
Primary Safety Outcome
时间窗: 30 days
The safety endpoint for this study is a Composite Safety Endpoint (CSE) defined as the proportion of subjects with one or more device- or procedure-related serious adverse events (SAEs) through 30 days post-procedure.
次要结局
未报告次要终点
研究者
研究点 (6)
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