Wireless optical capsule to detect upper gastrointestinal bleeding

A Prospective Study to Evaluate the Diagnostic Performance of a Wireless Optical Sensor Capsule in Detection of Upper Gastrointestinal Bleeding

This trial will test a swallowed wireless optical capsule (HemoPill) to see if it can detect bleeding in adults with suspected upper gastrointestinal bleeding.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 193 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Shatin, Hong Kong Island)
• Trial ID: NCT06715293 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with symptoms or signs of suspected upper GI bleeding (for example melena, coffee-ground vomiting, prior hematemesis) who can undergo OGD within 24 hours and can safely swallow the capsule are ideal candidates.

Not a fit: Patients with ongoing massive hematemesis, unstable hemodynamics, contraindications to capsule ingestion or OGD (including known bowel obstruction, implanted electromedical devices, prior major GI resection, or pregnancy) are unlikely to benefit from this test.

Why it matters

Potential benefit: If successful, the device could offer a quick, non-invasive way to identify patients with active upper GI bleeding and help decide who needs urgent endoscopy.

How similar studies have performed: Preclinical work showed high sensitivity and specificity and a small pilot in 20 patients reported 80% sensitivity and 87.5% negative predictive value, but larger prospective validation is still needed.

Eligibility criteria

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 this trial is running

Shatin, Hong Kong Island

• 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

Conditions: Melena, Gastrointestinal Bleeding, Hematemesis, GIB, gastrointestinal bleeding, melena, per rectal bleeding, coffee ground vomiting