The PillSense System, a novel blood-sensing swallowed capsule device, has shown high accuracy in detecting blood in patients with clinically suspected upper gastrointestinal bleeding (UGIB). In a study, the capsule demonstrated a sensitivity of 92.9% and a specificity of 90.6% in detecting UGIB.
The study, conducted by Karl Akiki, MD, and colleagues at the Mayo Clinic College of Medicine and Science, was published in Gastrointestinal Endoscopy. It involved an open-label, single-arm, comparative clinical trial with 126 adult participants suspected of UGIB. The PillSense System, developed by EnteraSense Ltd., uses an optical sensor to detect blood in the upper GI tract and transmits data to an external receiver. Participants underwent esophagogastroduodenoscopy (EGD) within 4 hours of capsule administration and were monitored for up to 21 days to confirm capsule passage.
The results showed that 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. The mean PillSense recording time was 6.71 minutes. The study also reported positive and negative predictive values of 74.3% and 97.8%, respectively. No adverse events related to the PillSense System or capsule ingestion were reported.
The researchers concluded that the PillSense System is a highly accurate and rapid method for detecting UGIB. The device is simple to deploy, and the results are easy to interpret. The successful passage of the capsule through the GI tract in all patients who completed the study indicates its safety. The PillSense System could potentially improve the efficiency of diagnosing UGIB, thereby improving patient outcomes and possibly altering the diagnostic and treatment approach for patients with suspected UGIB.