A Single-Center, Evaluator-Blinded, Retrospective, Pivotal Clinical Trial to Evaluate the Efficacy of Heuron CTA, a Brain Image Detection and Diagnostic Support Software, for Assessing Suspected Large Vessel Occlusion Using Brain CT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Heuron Inc.
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion
研究概览
简要总结
This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. If it performs well, it may help doctors diagnose these conditions more quickly and effectively.
详细描述
This study aims to evaluate the efficacy of Heuron CTA in assisting the diagnosis of suspected large vessel occlusion using brain CT angiography. The study will determine whether Heuron CTA meets the predefined clinical success criteria, where the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%, using the final clinical diagnosis by a group of surgeons as the reference standard. If Heuron CTA meets the success criteria, it will be considered effective in assisting in the diagnosis of large vessel occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older who visited the clinical trial institution for brain CTA images between January 2020 and May 2021, and from November 2021 until IRB approval
- •Individuals classified into the positive or negative group based on the following criteria:
- •Positive group: Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images -- Negative group: Diagnosed as either not having large vessel occlusion or as normal after brain CTA images
排除标准
- •Cases with poor-quality or incomplete brain CTA images7)
- •Cases where intracranial prosthetic implants (e.g., catheters, coils) were present
- •Cases that were previously used for AI model training and internal validation
- •Any other cases deemed unsuitable for participation in the clinical trial based on the investigator's judgment * Specific reasons were recorded in the case report form.
研究组 & 干预措施
Positive Group
Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images
干预措施: Heuron CTA (Device)
Negative group
Diagnosed as either not having large vessel occlusion or as normal after brain CTA images
干预措施: Heuron CTA (Device)
结局指标
主要结局
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion
时间窗: Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion were assessed by calculating their 95% confidence intervals (CIs) and determining whether the lower bound exceeded the clinical success criterion of 80%. The Clopper-Pearson confidence interval method12) was used to calculate the 95% CI.
次要结局
- Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion(Within 8 weeks after collecting data)
- Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel(Within 8 weeks after collecting data)
- Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria(Within 8 weeks after collecting data)