A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery
研究概览
地位
干预/治疗
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must be at least 18 years of age or older;
- Have an existing clinically ordered CT image within 2 weeks of the study; or
- Have an existing clinically ordered MR image within 2 weeks of the study;
- Provide written informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study;
- Be able to communicate effectively with clinical study personnel
Exclusion Criteria:
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Video Augmentation
Qualitative assessment of the value of video-based navigation system
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Assessment of value of video-based navigation system
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist
大体时间:Assessment is immediate, following operation.
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The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.
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Assessment is immediate, following operation.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Data Recording for Retrospective Analysis
大体时间:Data is recorded during case.
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The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow. Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:
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Data is recorded during case.
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合作者和调查者
调查人员
- 首席研究员:Gary L Gallia, M.D., Ph.D.、Johns Hopkins Hospital Department of Neurosurgery
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- J11101
- NA_00051786 (其他标识符:JHMIRB)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Video Augmentation的临床试验
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development招聘中
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Université Blaise Pascal, Clermont-Ferrand撤销