Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,650
- 试验地点
- 1
- 主要终点
- neoplasia detection rate
研究概览
简要总结
This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.
详细描述
This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation & Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis.
This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant must meet ALL of the following criteria to be considered eligible for the study:
- •Male or Female, aged 18 years or above.
- •Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.
- •Participant is willing and able to give informed consent for participation in the study.
- •Exclusion Criteria
- •The participant may not enter the study if ANY of the following apply:
- •Patients with endoscopically active severe oesophagitis
- •Poor bowel preparation
排除标准
- 未提供
结局指标
主要结局
neoplasia detection rate
时间窗: during the procedure, up to 24 weeks, at 1 year, through study completion
neoplasia detection rate of the AI algorithms in different locations of the GI tract.
次要结局
- Endoscopist neoplasia detection rate(during the procedure, up to 24 weeks, at 1 year, through study completion)
- Accuracy of AI diagnosis(during the procedure, up to 24 weeks, at 1 year, through study completion)