Speech and Image Recognition Based System in Improving Reporting Quality During Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The integrity of colonoscopy report
研究概览
简要总结
In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years old;
- •Able to read, understand and sign an informed consent;
- •The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
- •Patients requiring colonoscopy.
- •Males or females who are over 18 years old;
- •After qualified medical education and obtaining the Physician's Practice License.
排除标准
- •Have drug or alcohol abuse or mental disorder in the last 5 years;
- •Pregnant or lactating women;
- •Patients with known multiple polyp syndrome;
- •patients with known inflammatory bowel disease;
- •known intestinal stenosis or space-occupying tumor;
- •known colon obstruction or perforation;
- •patients with a history of colorectal surgery;
- •Patients with a previous history of allergy to pre-used spasmolysis;
- •Unable to perform biopsy due to coagulation disorders or oral anticoagulants;
- •High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
- •The researcher believes that the subjects are not suitable for participating in clinical trials.
研究组 & 干预措施
with Artificial intelligence assistant system
Endoscopists would complete the colonoscopy report with the assistance of the artificial intelligence system.
干预措施: Artificial intelligence assistant system (Diagnostic Test)
without Artificial intelligence assistant system
Endoscopists would complete the colonoscopy report without special prompts.
结局指标
主要结局
The integrity of colonoscopy report
时间窗: One month
Report integrity with or without AI-assisted. Calculation method = number of information recorded / total number of information need to record x 100%
次要结局
- The integrity of capturing anatomical landmarks(One month)