Capsule Device Detects Upper GI Bleeding with High Specificity and Sensitivity

This guide covers the PillSense System, a novel, swallowable, blood-sensing capsule designed for the rapid, non-invasive detection of acute upper gastrointestinal bleeding (UGIB). We will review its performance in a recent clinical trial and discuss its potential role in the clinical decision-making pathway.

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A revolutionary swallowable capsule that could transform how we diagnose gastrointestinal bleeding

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The Clinical Trial Results

In a recent landmark comparative clinical trial, Akiki and colleagues evaluated the safety and efficacy of the PillSense System (1). The authors enrolled 126 adults (mean age, 62.4 years; 59.5% men) with suspected UGIB at Mayo Clinic in Rochester. Participants underwent esophagogastroduodenoscopy (EGD) within 4 hours of capsule administration and were monitored up to 21 days to confirm capsule passage.

The numbers are impressive:

The capsule correctly detected the presence of blood in 26 out of 28 cases and the absence of blood in 87 out of 96 cases compared with EGD, demonstrating a sensitivity and specificity of 92.9% (95% CI, 76.5-99.1) and 90.6% (95% CI, 82.9-95.6), respectively, as well as positive and negative predictive values of 74.3% and 97.8%. The positive and negative likelihood ratios were 9.9 and 0.08. The mean PillSense recording time was 6.71 minutes (1).

Why This Matters