COPENHAGEN, Denmark — A real-time, blood-sensing capsule (PillSense, EnteraSense Ltd) that detects upper gastrointestinal bleeding (UGIB) is safe and effective for patients before undergoing upper endoscopy, according to results from the first US open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB. It is also the largest such trial.
This tool is rapidly deployed, safe to use, and easy to interpret, study researchers say. In under 7 minutes, the capsule correctly detected the presence of blood in 26 of 28 patients and its absence in 87 of 96 patients, as confirmed afterward by esophagogastroduodenoscopy (EGD).
“The use of the PillSense system will positively impact patient outcomes by providing early diagnosis, triaging, and directing care for UGIB,” said Karl Akiki, MD, study lead, who is in the Division of Gastroenterology and Hepatology at the Mayo Clinic, Rochester, Minnesota. He presented the results were here at the United European Gastroenterology (UEG) Week 2023.