NCT00953277已完成4 期
A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Surgeon Assessment of Technical Feasibility
研究概览
简要总结
The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age, but ≤70 years of age;
- •IIEF EF Domain*1 score ≥ 22;
- •be able to effectively communicate with study personnel;
- •be considered by the physician to be available for subsequent visits;
- •be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;
- •sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and
- •require radical prostatectomy.
排除标准
- •prior surgery in the last 6 months which could affect sexual function;
- •history of Peyronie's disease;
- •significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);
- •treatment for major psychiatric disorders;
- •history of penile implant or prosthesis;
- •history of diabetic neuropathy;
- •life expectancy of less than two years;
- •concurrently involved in another investigational study;
- •uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;
- •currently receiving or planned treatment with chemotherapy or radiation therapy;
- •diagnosis of bony metastasis;
- •known allergy or severe intolerance to PDE-5 inhibitors; or
- •cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.
结局指标
主要结局
Surgeon Assessment of Technical Feasibility
时间窗: At time of surgery
次要结局
- Erectile Recovery Rates(Month 1, 3, 6, 9, 12, 18 and 24)
- Adverse Events(Month 1, 3, 6, 9, 12, 18 and 24)
- Quality of Life Questionnaire(Month 1, 3, 6, 9, 12, 18 and 24)
- Continence Rates(Month 1, 3, 6, 9, 12, 18 and 24)
研究者
研究点 (2)
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