NCT03334344已完成不适用
Using Virtual Reality (VR) Models for Preoperative Planning
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
- 92
- 试验地点
- 11
- 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 partial nephrectomy) 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing robotic partial nephrectomy being performed by participating surgeon
- •Subject is willing to be randomized between intervention and control arms
排除标准
- •Cases involving subjects who are minors, pregnant or require an authorized representative for informed consent
- •Cases in which the subject has a solitary or horseshoe kidney
- •Cases in which the subject has more than two masses in the applicable kidney
- •Cases involving a bilateral operation
结局指标
主要结局
Total Operative Time
时间窗: During procedure
次要结局
- Number of Patients With an Intraoperative Complication(During procedure)
- Blood Loss(Measured at end of procedure)
- Number of Patients With Conversion to Open Surgery(During procedure)
- Clamp Time(Measured at end of procedure)
- Number of Patients With Conversion to Radical Nephrectomy(During procedure)
- Post-Op Complication(Measured up to 6 months after discharge)
- Patient Hospital Stay(Measured at time of patient discharge, up to 10 days)
- Number of Patients With a Positive Surgical Margin(Measured 1-2 weeks after discharge)
- Readmission(Measured up to 6 months after discharge)
研究者
研究点 (11)
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