Early DiAgnosis Real-Time Healthcare System for CANcer Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to evaluate whether the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps (≤5mm).
研究概览
简要总结
The purpose of the study is to assess whether the AI characterisation system of the CADDIE device improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps in the bowel during colonoscopy. Participants will either have a colonoscopy with the assistance of the CADDIE device characterisation AI system ("intervention group") or have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system ("control group"). The randomisation method of this trial will allocate enrolled participants to the "intervention" group and to the "control" group by a technique similar to flipping a coin.
详细描述
The CADDIE system comprises a computer attached to the output of the endoscopy stack and a screen which shows the normal video output of the colon in real-time. Using artificial intelligence (AI) software, it highlights the characteristics of a polyp to help the endoscopist in their optical diagnosis of the polyp histology. Pressing on a foot pedal, which is connected to the computer, presents the information from the AI software to the user as an overlay on the endoscopy screen in text format.
The CADDIE device is capable of recording the video output of the colon in real-time irrespective of whether the CADDIE's AI system is active.
In the endoscopist recruitment phase, we will identify endoscopists expertise and experience in colonoscopy.
In the study phase of the trial, the endoscopist will be kept the same for the CADDIE and control arm. At the beginning of each procedure, participant information will be entered into an electronic system (Redcap) which will generate a random allocation into one of two arms. The CADDIE arm involves a colonoscopy assisted by the CADDIE AI system (i.e., AI software). The control arm is a colonoscopy without the CADDIE's polyp characterisation AI system (i.e., standard practice). Each endoscopist will have the CADDIE device present during all endoscopy lists and will record all procedures in both CADDIE and control arms. The CADDIE's polyp characterisation system (i.e., AI software) will only be active in the CADDIE arm. The recordings in the control arms will allow an extra post-hoc assessment of how CADDIE might have performed compared to the actual assessment by the endoscopist.
In both arms of the trial, for each polyp the endoscopist detects, they will:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
- •Male and female participants aged 18 years or older at the time of informed consent.
- •Participants able to comprehend, sign and date the written informed consent document to participate in the study.
排除标准
- •Emergency and/or inpatient colonoscopies
- •Participants with inflammatory bowel disease (IBD)
- •Participants with current Colorectal Cancer (CRC)
- •Participants with a contraindication for biopsy or polypectomy. These include:
- •Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
- •Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders)
- •Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
结局指标
主要结局
The primary objective of this study is to evaluate whether the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps (≤5mm).
时间窗: 1 year
The primary endpoint will be the proportion of diminutive colorectal polyps optically diagnosed correctly by endoscopists (correct optical diagnoses divided by total number of diminutive polyps), expressed as a percentage, in the CADDIE arm compared to the control arm, with the polyp histopathology being referenced as the ground truth.
次要结局
- Assess the integration of the CADDIE system into the normal colonoscopy clinical workflow.(1 year)
- To determine whether using the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive polyps in the rectosigmoid area.(1 year)
- To assess the concordance of colonoscopy surveillance intervals in the CADDIE arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).(1 year)
- To assess the concordance of colonoscopy surveillance intervals in the control arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).(1 year)
- To determine whether using the CADDIE system improves the negative predicator value (NPV) of endoscopists for optically diagnosing diminutive adenomatous polyps in the rectosigmoid area.(1 year)
- To evaluate how the CADDIE system influences the endoscopists confidence in their OD.(1 year)
- To compare the accuracy of the colonoscopy surveillance intervals when the endoscopists uses the CADDIE system (CADDIE arm) compared to without the CADDIE system (control arm).(1 year)
- Evaluate the safety of the CADDIE system in clinical application.(1 year)