A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial

Background & Aims: Upper gastrointestinal bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality.Timely esophagogastroduodenoscopy (EGD) can be challenging from personnel, resource, and access perspectives.PillSense (EnteraSense Ltd, Galway) is a novel swallowed bleeding sensor for detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB.Methods: This is a prospective open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB performed at a tertiary care center.The PillSense System consists of an optical sensor and an external receiver that processes and displays data from the capsule as "Blood Detected" or "No Blood Detected".Patients underwent EGD within 4 hours of capsule administration; participants were followed up to 21 days to confirm capsule passage.Results: 126 patients were accrued to the study (59.5% males, mean age 62.4 ± 14.3 years).Sensitivity and specificity for detecting the presence of blood were 92.9% (p = 0.02) and 90.6% (p < 0.001), respectively.The capsule's positive and negative predictive values were 74.3% and 97.8%., respectively, and positive and negative likelihood ratios were 9.9 and 0.08, respectively.No adverse events or deaths occurred related to the PillSense System, and all capsules were excreted from patients on follow-up. Conclusions:The PillSense System is safe and effective for detecting the presence of blood in patients evaluated for UGIB prior to upper GI endoscopy.It is a rapidly deployed tool, with easyto-interpret results that will impact the diagnosis and triage of patients with suspected UGIB.(ClinicalTrials.gov,NCT05385224).