NCT05080088已完成不适用
A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
研究概览
简要总结
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :
- Colonoscopy Only Group
- Artificial intelligence only group (IA GI GENIUS ™ alone)
- Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
时间窗: 4 months
number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap.
次要结局
- Withdrawal time(4 months)
- Adenomas Rate according to their size(4 months)
- Adenomas Rate according to their morphology(4 months)
- Adenomas Rate according to their histology(4 months)
- Caecal Intubation Rate(4 months)
- Adverse effects(4 months)
研究者
Clément Delliot
medical student
Centre Hospitalier Universitaire de Nīmes
研究点 (1)
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