Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,596
- 试验地点
- 1
- 主要终点
- ADR
研究概览
简要总结
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.
详细描述
This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).
Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms:
- Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CADe system.
- Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.
The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.
Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Allocation will be concealed; the patients and the participating endoscopists will not be informed of the treatment group.
入排标准
- 年龄范围
- 45 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- •Age 45-89 years
排除标准
- •Patients undergoing emergency colonoscopy
- •Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
结局指标
主要结局
ADR
时间窗: 30 days
The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected.
次要结局
- Mean number of adenomas per colonoscopy (APC)(30 days)
- Sessile serrated lesions (SSL) detection rate(30 days)
- Sessile serrated lesion per Colonoscopy (SSLPC)(30 days)
- Advanced lesion detection rate (ALDR)(30 days)
- Proximal ADR(30 days)
- Proportion neoplastic and non-neoplastic polyps(30 days)
- CADe utilization rate(Through study completion, an average of 3 years)
研究者
Daniel Von Renteln
Gastroenterologist, Principal Scientist, MD, PhD
Centre hospitalier de l'Université de Montréal (CHUM)