Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,320
- 试验地点
- 2
- 主要终点
- Adenoma detection yield
研究概览
简要总结
A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.
详细描述
Multi-center, three-arm, randomized, controlled, open-label study.
Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups):
Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery & G-EYE® aided colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening and surveillance population for Adenoma and CRC.
- •The patient must understand and sign a written informed consent for the procedure.
排除标准
- •Subjects with inflammatory bowel disease;
- •Subjects with a personal history of hereditary polyposis syndrome;
- •Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- •Subjects with diverticulitis or toxic megacolon;
- •Subjects with prior colonic surgery (exclusion appendectomy)
- •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
结局指标
主要结局
Adenoma detection yield
时间窗: Upon histology results (up to 30 days)
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery \& G-EYE® aided colonoscopy
次要结局
- Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)(Upon histology results (up to 30 days))
- Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)(Upon histology results (up to 30 days))
- Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)(Upon histology results (up to 30 days))