Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- AdventHealth
- 试验地点
- 2
- 主要终点
- Time to potency
研究概览
简要总结
The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.
详细描述
The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.
For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between the ages 40-
- •Primary diagnosis of prostate cancer requiring surgical intervention
- •Have a willingness to comply with follow-up requirements.
- •Have ability to provide full written consent.
- •Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or
- •Planned elective radical prostatectomy with bilateral full nerve sparing technique.
- •Patients who currently have a pre-operative SHIM > 19
排除标准
- •Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
- •Has any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment.
- •Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:
- •Diabetes Type I or Type II
- •Advanced atherosclerotic vascular disease
- •Is unable to sign or understand informed consent.
- •Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
- •Has a documented medical history of drug or alcohol abuse within last 12 months.
- •Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
- •Known sensitivity to glutaraldehyde or ethanol.
- •Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- •Has had prior hormonal therapy such as Lupron or oral anti-androgens.
- •Living outside of United States
- •Partial nerve sparing technique used during Radical Prostatectomy
结局指标
主要结局
Time to potency
时间窗: 14 days to 12 months post prostatectomy
Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.
次要结局
- Time to continence(14 days to 12 months post prostatectomy)
研究者
Vipul Patel, MD
Dr. Vipul R. Patel
AdventHealth