Telemetric capsule-based upper gastrointestinal tract - blood detection - first multicentric experience

Area of Science:

• Gastroenterology
• Medical Devices
• Diagnostic Technology

Background:

• Current risk stratification for upper gastrointestinal bleeding (UGIB) relies on clinical parameters and risk scores.
• Real-time blood detection using ingestible sensor capsules offers a novel approach.

Purpose of the Study:

• To evaluate the clinical utility and safety of the HemoPill® acute capsule for real-time blood detection in routine clinical practice.
• To assess the system's performance in identifying or excluding gastrointestinal bleeding.

Main Methods:

• A retrospective analysis of 61 consecutive patients across 12 international hospitals.
• The HemoPill® acute capsule was used for suspected UGIB, small bowel bleeding, or rebleeding exclusion.
• Primary endpoints included technical success and bleeding detection/exclusion; secondary endpoints were adverse events and clinical course changes.

Main Results:

• Technical success rate was 98%.
• The capsule detected bleeding in 58% of cases (35/60), with endoscopy confirming bleeding in 57% of these positive cases (20/35).
• No rebleeding occurred in capsule-negative patients (25/60), and emergency endoscopy was avoided in 72% of these cases (18/25). No serious adverse events were reported.

Conclusions:

• HemoPill® acute capsule-based blood detection is feasible and safe for evaluating gastrointestinal bleeding.
• Negative capsule results can potentially reduce the need for urgent endoscopic procedures.