招募中 NCT06848400

模擬家居場景下膠囊胃內窺鏡用於胃部疾病篩查

未指定不適用

這項臨床試驗的目的是評估人工智能整合膠囊胃鏡(ACG)系統在模擬家居使用條件下檢測上消化道(UGI)異常的診斷準確性。研究亦會比較人工智能輔助判讀與人工判讀ACG數據的診斷準確性及時間效率。

適應症:Gastric Lesion、Gastritis、Upper Gastrointestinal Bleeding (UGIB)、Gastric Dysplasia、Gastric Ulcer、Gastric Neoplasms

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。