试验雷达 AI | ||
|---|---|---|
临床试验 NCT05244278 针对人工智能目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies 1,596 随机化 双盲
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05244278是一项针对人工智能的干预性研究试验，目前试验状态为招募中。试验始于2023年8月1日，计划招募1,596名患者。该研究由Centre hospitalier de l'Université de Montréal (CHUM)主导，预计于2027年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年3月5日。
简要概括
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...
显示更多官方标题
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
疾病
人工智能其他研究标识符
- 2022-10312, 21.297
NCT编号
实际开始日期
2023-08-01
最近更新发布
2025-03-05
预计完成日期
2027-01-01
计划入组人数
1,596
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Polyp detection
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
主要目的
诊断
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. | Medtronic-GI genius (CADe system for detecting colorectal polyps) Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. |
无干预Colonoscopy performed in room without CADe system In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
ADR | The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected. | 30 days |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean number of adenomas per colonoscopy (APC) | Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed | 30 days |
Sessile serrated lesions (SSL) detection rate | Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified | 30 days |
Sessile serrated lesion per Colonoscopy (SSLPC) | Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies | 30 days |
Advanced lesion detection rate (ALDR) | Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma \>10mm was at least 1. | 30 days |
Proximal ADR | Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure | 30 days |
Proportion neoplastic and non-neoplastic polyps | Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology) | 30 days |
CADe utilization rate | CADe utilization rate (when available in the room). Since the CADe utilization rate cannot be assessed without revealing the ongoing trial to the endoscopists, two voluntary self-reported measures and a partially objective measure. First, endoscopists will be surveyed via email during and at the end of the trial regarding their use of CADe, while keeping them unaware of the ongoing trial. Second, the proportion with endoscopy reports for which is is explicitly stated that CADe was used will be computed. | Through study completion, an average of 3 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
45 Years
适龄性别
全部
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-89 years
- Patients undergoing emergency colonoscopy
- Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Centre hospitalier de l'Université de Montréal (CHUM)研究责任方
Daniel Von Renteln, 主要研究者, Gastroenterologist, Principal Scientist, MD, PhD, Centre hospitalier de l'Université de Montréal (CHUM)
没有联系数据。
1 位于 1 个国家/地区的研究中心
Quebec
Centre Hospitalier Universitaire de Montréal, Montreal, Quebec, Canada
Samira Hanin, 联系人, 514-890-8000, [email protected]
Daniel von Renteln, MD, PhD, 主要研究者
招募中