Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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's Treatment.
The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.
详细描述
Current BPH treatments fall into two major categories:
-
Surgical removal/destruction of prostatic tissues:
-
Transurethral resection of the prostate (TURP)
-
Holmium laser enucleation of the prostate (HoLEP)
-
Aquablation - (Procept)
-
Prostatic artery embolization (PAE)
-
Minimally-invasive Surgical Therapies (MISTs)
-
Itind (now Olymus)
-
Urolift (now Teleflex)
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Rezum (now Boston Scientific)
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TUNA
-
Zenflow (in trials)
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Butterfly Medical (in trials)
The solutions in the first category rely in removing or destroying prostatic tissue. Though effective at reducing urinary symptoms, this damage to the tissue can cause a number of complications. The "non-surgical" solutions fall into the second category. One of the best-studied of these, Urolift, is an implant-based therapy, using internal sutures that are deployed though the urethra that pull the prostatic tissue away from the urethra lumen, repristinating urethral patency. A significant percentage of cases show recurrence of symptoms due to the fact that the prostate continues to grow. Looking at the currently available treatment options, the longer-lasting surgical procedure (group 1). Group 1 procedures, especially TURP, remain "the gold standard" by which all other BPH treatment options are measured.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 40-75 years of age
- •Diagnosed with Benign prostatic hyperplasia (BPH)
- •Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
- •Signed the study informed consent form (ICF)
- •Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
- •Presence of clinical varicocele (preferably grade II or III - Dubin & Amelar.
排除标准
- •Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
- •Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
- •Prostate with large intravesical median lobe
- •Patients with sub-clinical varicocele
- •Post-void residual volume (PVR) > 110ml
- •IPSS (International Prostate Symptoms Score) >24
- •Patients with clinical history of chronic prostatitis.
- •Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
- •Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
- •Patients that can not be under general anesthesia
- •Patients on blood thinners, or with coagulation related issues, TTP
- •Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
- •History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
- •Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
- •Subject currently participating in other investigational studies unless approved by the Sponsor in writing
结局指标
主要结局
PRIMARY SAFETY ENDPOINT
时间窗: will be assessed up to 12-month post-procedure follow-up.
Assess the safety of the Vivifi's Treatment through the rate \& type of the procedure related complications, such as bleeding, infection or other tissue damage.
PRIMARY EFFICACY ENDPOINT
时间窗: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
Assess the changes in International Prostate Symptoms Score (IPSS) from baseline to post-procedure. The score range of the questionnaire is 0 to 35. A higher score indicates worse symptomatic.
次要结局
- SECODARY EFFICACY ENDPOINT 2(to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.)
- SECODARY EFFICACY ENDPOINT 3(to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.)
- SECODARY EFFICACY ENDPOINT 1(to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.)
- SECODARY EFFICACY ENDPOINT 4(to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.)