NCT05318495Unknown不适用
A Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of SC to That of Artificial Intelligence (CAD-EYE) Aided Colonoscopy and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy.
Dr. Horst Schmidt Klinik GmbH2 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Additional adenoma detection yield
研究概览
简要总结
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:
- The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
- CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
- The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.
详细描述
Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices:
- The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
- CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
- The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning.
Total of up to 372 patients will be randomized,186 to each of the two tandems
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
Additional adenoma detection yield
时间窗: 6 weeks
additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard coloscopy 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
研究者
Prof. Dr. Ralf Kiesslich
Prof.
Dr. Horst Schmidt Klinik GmbH
研究点 (2)
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