Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Additional Adenoma Detection
研究概览
简要总结
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.
详细描述
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Screening and surveillance population for Adenoma and CRC.
- •Subjects age is at least 18 years
- •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
研究组 & 干预措施
Standard Colonoscopy followed by CAD-EYE
Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: Standard Colonoscopy (Device)
Standard Colonoscopy followed by CAD-EYE
Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: CAD-EYE (Device)
CAD-EYE followed by Standard Colonoscopy
Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: Standard Colonoscopy (Device)
CAD-EYE followed by Standard Colonoscopy
Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: CAD-EYE (Device)
Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy
Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: Standard Colonoscopy (Device)
Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy
Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: G-EYE Colonoscopy (Device)
Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy
Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: CAD-EYE (Device)
Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy
Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: Standard Colonoscopy (Device)
Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy
Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: G-EYE Colonoscopy (Device)
Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy
Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
干预措施: CAD-EYE (Device)
结局指标
主要结局
Additional Adenoma Detection
时间窗: Upon histology results (up to 30 days)
Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy
次要结局
未报告次要终点