Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
详细描述
The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and/or remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 45-80 years of age
- •Diagnosed with Benign prostatic hyperplasia (BPH)
- •Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
- •Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
- •Assessment of future paternity plans
- •Signed the study informed consent
- •Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
排除标准
- •Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
- •Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
- •Intravesical prostatic protrusion (IPP) > 10 mm
- •Post-void residual volume (PVR) > 200ml
- •IPSS QoL score ≤ 3
- •Prostate cancer diagnosis, suspicious DRE, or PSA > 10ng/mL
- •Patients with clinical history of chronic prostatitis.
- •Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.
- •Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury
- •Patients who are unable to undergo the required anesthesia for the procedure
- •Patients on testosterone replacement therapy
- •Patients unable to hold blood thinners, or with coagulation related issues
- •Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)
- •Diagnosis of Hidradenitis suppurativa
结局指标
主要结局
Primary Safety Endpoint
时间窗: 24 month follow-up
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months
时间窗: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.
次要结局
- Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)(From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.)
- Mean change from baseline in prostate volume (cc) measured by MRI(From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.)
- Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow(From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.)
- Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan(Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.)