P2045 - Is My Patient Bleeding? A Prospective Clinical Trial of a Novel Swallowed Bleeding Sensor

Award: Presidential Poster Award

Karl Akiki, MD, Tala Mahmoud, MD, Lea N. Sayegh, MD, Kristin E. Lescalleet, DO, Barham Abu Dayyeh, MD, MPH, Louis M. Wong Kee Song, MD, Mark V. Larson, MD, David H. Bruining, MD, Nayantara Coelho-Prabhu, MBBS, Navtej S. Buttar, MD, Robert E. Sedlack, MD, MHPEd, Vinay Chandrasekhara, MD, Cadman L. Leggett, MD, Ryan J. Law, DO, Elizabeth Rajan, MD, Ferga Gleeson, MBBCh, Jeffrey Alexander, MD, Andrew Storm, MD
Mayo Clinic, Rochester, MN

Introduction: Upper gastrointestinal bleeding (UGIB) is a common emergency associated with high resource utilization, morbidity, and mortality. The gold standard for diagnosis is Esophagogastroduodenoscopy (EGD). However, timely EGD can be challenging from a time, personnel, and access perspective. PillSense, an FDA-approved device, is a novel swallowed bleeding sensor (PillSense, EnteraSense Ltd, Galway, Ireland) developed to provide rapid and accurate blood detection, aid in triage, and guide clinical decision-making for patients with suspected UGIB.

Methods: This was the first U.S. and largest open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB. The PillSense System consists of an optical sensor capsule intended to detect the presence of blood by measuring the absorption of multiple wavelengths of light and an external receiver that processes and displays data relayed wirelessly from the capsule as simply “Blood Detected” or “No Blood Detected” (Figure1). Patients underwent EGD within 4 hours of capsule administration, and results of both modalities were compared; participants were followed for 21 ±3 days to confirm capsule passage through the gastrointestinal tract. Endoscopists were blinded to the capsule result.

Results: 131 patients were enrolled (59.5% males, mean age 62.4 ± 14.3 years). The most common presenting symptoms for UGIB were melena (52%), anemia (41%), and hematemesis (15%). The capsule correctly detected the presence of blood in 26/28 and absence in 87/96. Sensitivity and specificity were 92.9% (p = 0.024) and 90.6% (p < 0.0001), respectively. Positive (+) and negative (-) likelihood ratios (LR) were 9.9 and 0.08, respectively. PillSense recording time was 6.71 ±1.17 minutes. Capsule passage from the patient was confirmed radiographically or visually on stool inspection in 110 patients. The average capsule transit time was 3.6 days; no capsule retention was documented. No adverse events or death occurred related to the PillSense System. Pillsense performance and characterization of bleeding are described in table 1.

Discussion: The PillSense System is safe and effective for detecting blood in patients being evaluated for UGIB prior to upper endoscopy. This tool is rapidly deployed, safe to use, easy to interpret, and may therefore assist in the efficient diagnosis of UGIB to improve patient outcomes and reduce healthcare costs.



Disclosures:


Karl Akiki, MD, Tala Mahmoud, MD, Lea N. Sayegh, MD, Kristin E. Lescalleet, DO, Barham Abu Dayyeh, MD, MPH, Louis M. Wong Kee Song, MD, Mark V. Larson, MD, David H. Bruining, MD, Nayantara Coelho-Prabhu, MBBS, Navtej S. Buttar, MD, Robert E. Sedlack, MD, MHPEd, Vinay Chandrasekhara, MD, Cadman L. Leggett, MD, Ryan J. Law, DO, Elizabeth Rajan, MD, Ferga Gleeson, MBBCh, Jeffrey Alexander, MD, Andrew Storm, MD. P2045 - Is My Patient Bleeding? A Prospective Clinical Trial of a Novel Swallowed Bleeding Sensor, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.