Wireless optical capsule to detect upper gastrointestinal bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, diagnostic validation of the next-generation HemoPill acute capsule in adults presenting with signs of upper gastrointestinal bleeding who will undergo oesophago-gastro-duodenoscopy (OGD) within 24 hours. Participants will swallow the wireless optical capsule before OGD and results from the capsule will be compared to endoscopic findings to determine sensitivity, specificity, and predictive values. The study builds on preclinical work and a small pilot that suggested promising sensitivity and negative predictive value. A larger sample will be enrolled to provide more robust estimates of diagnostic performance in a real-world hospital setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Prince of Wales Hospital
  Shatin, Hong Kong Island, Hong Kong Recruiting

Study contacts

• Principal investigator: Louis HS Lau, FRCP — Chinese University of Hong Kong
• Study coordinator: Louis HS Lau, FRCP
• Email: louishslau@cuhk.edu.hk
• Phone: 26370428

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.