A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 2,160
- 试验地点
- 2
- 主要终点
- Adenoma Per Colonoscopy (APC) (AI compared with AG)
研究概览
简要总结
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
详细描述
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms:
(i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age ≥ 45 years old
- •Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection)
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Subjects with inflammatory bowel disease
- •Subjects with a personal history of polyposis syndrome
- •Subjects with suspected chronic stricture potentially precluding complete colonoscopy
- •Subjects with diverticulitis or toxic megacolon
- •Subjects with a history of radiation therapy to abdomen or pelvis
- •Pregnant or lactating female subjects
- •Subjects who are currently enrolled in another clinical investigation.
- •Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- •Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- •Any patient condition deemed too risky for the study by the investigator
- •Previous colonic surgery (except for appendectomy)
研究组 & 干预措施
Standard Colonoscopy ("SC")
Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
干预措施: Standard Colonoscopy (Device)
Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")
Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
干预措施: Artificial Intelligence Aided Colonoscopy (GI Genius™) (Device)
Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)
Subjects enrolled to arm 3 ("AG") will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).
干预措施: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy (Device)
结局指标
主要结局
Adenoma Per Colonoscopy (APC) (AI compared with AG)
时间窗: Upon histology results (up to 30 days)
Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG.
次要结局
- Adenoma Per Colonoscopy (APC) (SC compared with AG)(Upon histology results (up to 30 days))
- Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG)(Upon histology results (up to 30 days))