NCT03870269已完成不适用
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ceevra, Inc.
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Total operative time
研究概览
简要总结
A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing robotic prostatectomy being performed by participating surgeon
- •Patient is willing to be randomized between intervention and control arms
排除标准
- •Patients with prior pelvic radiation
- •Patients with prior androgen deprivation therapy
- •Patients with prior localized ablative therapy
- •Patients with prior TURP or other surgical BPH treatment
结局指标
主要结局
Total operative time
时间窗: During procedure, not to exceed 12 hours
次要结局
- Postoperative oncologic stage (T stage)(Measured up to 3 months after discharge)
- Postoperative prostate-specific antigen (PSA)(Measured up to 12 months after disccharge)
- Blood loss (measured in cubic centimeters)(Measured at end of procedure, not to exceed 12 hours)
- Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure(During procedure, not to exceed 12 hours)
- Postoperative Gleason Score(Measured up to 3 months after discharge)
- Readmission(Measured up to 6 months after discharge)
- Intraoperative complication(During procedure, not to exceed 12 hours)
- Patient hospital stay(Measured at time of patient discharge, up to 10 days)
- Postoperative erectile function(Measured via survey up to 18 months after discharge)
- Postoperative continence(Measured via survey up to 18 months after discharge)
- Positive tumor margin (assessed via standard post-operative biopsy)(Measured 1-2 weeks after discharge)
研究者
研究点 (2)
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