NCT05956977招募中不适用
Evaluation of 3D Ultrasound in Brain Tumor Surgery
University of Ulm2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Extent of resection
研究概览
简要总结
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion
排除标准
- •no ability for informed consent
结局指标
主要结局
Extent of resection
时间窗: 48 hours after surgery
Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
次要结局
- neurological outcome(both after surgery and at 3 months)
- image quality(during surgery)
- Accuracy of device(during surgery)
研究者
Jan Coburger
apl. Prof. Dr. med. Jan Coburger, Consultant
University of Ulm
研究点 (2)
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