A Prospective Study to Evaluate the Diagnostic Performance of a Wireless Optical Sensor Capsule in Detection of Upper Gastrointestinal Bleeding

What this Trial Is About

Researchers are evaluating the diagnostic performance of a wireless optical sensor capsule called HemoPill® to detect upper gastrointestinal bleeding (UGIB), a serious medical emergency that requires prompt hospitalization and resources. Current risk scores for predicting bleeding outcomes are not very accurate, so this study aims to validate a new, non-invasive device to better identify patients who need urgent care. Previous studies have shown promising sensitivity and specificity for the HemoPill® in detecting active bleeding without adverse events. Participants will swallow the HemoPill® capsule, which uses sensors to detect bleeding in the upper gastrointestinal tract. Within 24 hours, participants will also undergo an oesophago-gastro-duodenoscopy (OGD) procedure to compare findings with the capsule results. The study is non-randomized and single-blinded, focusing on adults with suspected UGIB. The study will measure the presence of active bleeding during OGD, technical success, safety events, capsule retention, and the time from capsule ingestion to positive bleeding detection. During the study, participants will be monitored for adverse events up to 30 days after the procedures. Researchers will collect data from the capsule and OGD to assess the accuracy of the HemoPill® in detecting bleeding. The study will also track capsule retention and time to detection of bleeding signals. The total participation involves capsule ingestion followed by OGD within 24 hours and safety follow-up, aiming to improve risk assessment for patients with suspected UGIB.

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