NCT07633847尚未招募不适用
Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 3
研究概览
简要总结
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
详细描述
The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. The tool is not intended to replace clinical decision making.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all genders, races, ethnicities and geographical backgrounds, from 22 years of age or older.
- •Patient agrees to sign informed consent and follow all study procedures.
排除标准
- •In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- •In patients with cardiac pacemakers or other implantable electronic medical devices (MR unsafe devices only).
- •In patients with dysphagia with high risk of aspiration.
- •In pregnant women.
- •GI motility issues (gastroparesis)
- •GI dysmotility
- •Chronic opioid usage
- •Requires endoscopic placement
- •In patients with endoscopic biopsies within one week of scheduled capsule ingestion
- •No NSAID use within 14 days of scheduled capsule ingestion
- •No GLP-1 drugs within 7 days of scheduled capsule ingestion
研究者
研究点 (3)
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