A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Intracranial aneurysm size
研究概览
简要总结
the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75y, no gender limitation.
- •non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
- •Intracranial aneurysm was not treated.
- •Inclusion criteria of images:
- •the number of detector rows of Computed Tomography(CT) is more than 16 rows.
- •slice thickness ≤ 0.625mm, whole-brain image is considered.
- •Both plain scan sequences and enhancer sequence are required.
排除标准
- •combined with cerebral hemorrhage;
- •combined with cerevascular malformation or cerebral occupying lesion;
- •fusiform aneurysm or dissection aneurysm;
- •intracaverous internal carotid artery aneurysm;
- •Exclusion criteria of images:
- •none DICOM format;
- •quality score less than 3 scores;
- •metal artifacts existance.
结局指标
主要结局
Intracranial aneurysm size
时间窗: 10 years
次要结局
- Intracranial aneurysm width(10 years)
- Size ratio(10 years)
- Intracranial aneurysm height(10 years)
- Parent artery diameter(10 years)
- Intracranial aneurysm volume(10 years)
- Intracranial aneurysm neck diameter(10 years)
- Aspect ratio(10 years)
研究者
Wang Shuo
Department of neurosurgery
Beijing Tiantan Hospital