Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,100
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.
The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).
详细描述
Any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited.
The patient will be offered to participate in the study. The information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits).
A period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study.
After the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. The use of the Genius® system will depend on the randomization that will be performed at the start of the colonoscopy.
This randomization will be done in the computer examination room using the randomization software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Patient scheduled for total colonoscopic exploration, during the period study
- •Patient over or equal to 18 years
- •ASA 1, ASA 2, ASA 3
- •No participation in another clinical study
- •Certificate of non opposition signed
排除标准
- •Patient under 18 years old
- •ASA 4, ASA 5
- •Pregnant woman
- •Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- •Patient referred for resection of a known polyp
- •Inflammatory bowel disease
- •Known colonic stenosis
- •Diverticulitis less than 6 weeks old
- •Patient unable to give consent or protected by law
- •Opposition expressed for inclusion in the study
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: 1 day
percentage of colonoscopy with one or more adenoma of the colon
次要结局
- Advanced Neoplasia Detection Rate (ANDR)(1 day)
- Proximal Serrated Polyp Detection Rate (PSPDR)(1 day)
- Morbidity: perforation rate (%)(7 days after procedure)
- Morbidity: bleeding rate (%)(7 days after procedure)
- Polyp Detection Rate (PDR)(1 day)
- Time to reach caecum (sec)(1 day)
- Caecal intubation rate (%)(1 day)
- The factors influencing the Adenoma Detection Rate (ADR)(1 day)