这项临床试验的目的是评估人工智能整合胶囊胃镜(ACG)系统在模拟家居使用条件下检测上消化道(UGI)异常的诊断准确性。研究亦会比较人工智能辅助判读与人工判读ACG数据的诊断准确性及时间效率。
适应症:Gastric Lesion、Gastritis、Upper Gastrointestinal Bleeding (UGIB)、Gastric Dysplasia、Gastric Ulcer、Gastric Neoplasms
入组条件
纳入标准
- Aged 18 years or older.
- Individuals meeting the following criteria:
- i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.
- Willing to participate voluntarily in the clinical trial and provide written informed consent.
- Capable of communicating with researchers and complying with trial requirements.
排除标准
- Pregnant individuals.
- Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.
- Individuals with swallowing dysfunction.
- Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.
- Participants who are unable to comprehend and/or comply with physician instructions during the examination.
- Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.
入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。