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A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
NCT06715293 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Upper gastrointestinal bleeding (UGIB) is a common and potentially lethal medical emergency, which requires hospitalization and healthcare resources. Despite the changing epidemiology and advancement of endoscopic therapy in the recent decade, the all-cause mortality of UGIB remains high (\>2%). An accurate risk stratification is necessary to triage patients into low- or high-risk groups, in order to inform clinicians for the necessity and timing of urgent endoscopy. However, existing pre-endoscopy risk scores, such as the Glasgow-Blatchford score (GBS), Rockall score and AIMS65 score, are suboptimal in predicting relevant clinical outcomes. An alternative strategy for risk stratification is urgently warranted in patients with UGIB to guide the next step of management. In a pre-clinical study, the sensitivity and specificity of HemoPill® prototype were 95% and 87.5% respectively, when t

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Participants have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, prior hematemesis); 2. Participants will undergo urgent or elective OGD within 24 hours from recruitment; 3. Written consent obtained. Exclusion Criteria: 1. Contraindications for OGD (e.g. respiratory failure, suspected perforation); 2. Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness); 3. Cardiac pacemaker or implanted electromedical devices; 4. History of gastrectomy or bowel resection; 5. Ongoing fresh hematemesis requiring emergent endoscopy; 6. Unstable hemodynamics despite adequate resuscitation requiring emergent endoscopy (i.e. systolic blood pressure \<100mmHg or pulse rate \>100 per minute); 7. Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above); 8. Pregnancy.
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What it tests

  • Hemopill
  • OGD
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Where

1 site
Prince of Wales Hospital
Shatin, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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