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

From December 2023 to February 2024, the investigator conducted a pilot study and screened 51 adult subjects with symptoms and signs of suspected UGIB in Prince of Wales Hospital. Among them, the investigator recruited 20 eligible subjects to receive HemoPill® examination before oesophago-gastro-duodenoscopy (OGD). The overall sensitivity was 80% with a negative predictive value of 87.5%. The area-under-receiver-operating-characteristic curve was 0.633.

The pilot data demonstrated a huge potential for this novel, non-invasive, easy-to-use device as UGIB screening in the real-world. A large-scale, prospective validation study will be conducted to evaluate the diagnostic performance of the new generation HemoPill® acute capsule in UGIB.

Inclusion criteria

• Participants have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, prior hematemesis);
• Participants will undergo urgent or elective OGD within 24 hours from recruitment;
• Written consent obtained.

Exclusion criteria

• Contraindications for OGD (e.g. respiratory failure, suspected perforation);
• Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness);
• Cardiac pacemaker or implanted electromedical devices;
• History of gastrectomy or bowel resection;
• Ongoing fresh hematemesis requiring emergent endoscopy;
• Unstable hemodynamics despite adequate resuscitation requiring emergent endoscopy (i.e. systolic blood pressure <100mmHg or pulse rate >100 per minute);
• Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
• Pregnancy.