TY - JOUR
T1 - A novel blood-sensing capsule for rapid detection of upper GI bleeding
T2 - a prospective clinical trial
AU - Akiki, Karl
AU - Mahmoud, Tala
AU - Alqaisieh, Mohammad H.
AU - Sayegh, Lea N.
AU - Lescalleet, Kristin E.
AU - Abu Dayyeh, Barham K.
AU - Wong Kee Song, Louis M.
AU - Larson, Mark V.
AU - Bruining, David H.
AU - Coelho-Prabhu, Nayantara
AU - Buttar, Navtej S.
AU - Sedlack, Robert E.
AU - Chandrasekhara, Vinay
AU - Leggett, Cadman L.
AU - Law, Ryan J.
AU - Rajan, Elizabeth
AU - Gleeson, Ferga C.
AU - Alexander, Jeffrey A.
AU - Storm, Andrew C.
N1 - Publisher Copyright:
© 2024 American Society for Gastrointestinal Endoscopy
PY - 2024/5
Y1 - 2024/5
N2 - Background and Aims: Upper GI bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality. Timely EGD can be challenging from personnel, resource, and access perspectives. PillSense (EnteraSense Ltd, Galway, Ireland) is a novel swallowed bleeding sensor for the detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB. Methods: This prospective, open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB was 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 for 21 days to confirm capsule passage. Results: A total of 126 patients were accrued to the study (59.5% male; mean age, 62.4 ± 14.3 years). Sensitivity and specificity for detecting the presence of blood were 92.9% (P = .02) and 90.6% (P < .001), respectively. The capsule's positive and negative predictive values were 74.3% and 97.8%, and positive and negative likelihood ratios were 9.9 and .08. 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 before upper GI endoscopy. It is a rapidly deployed tool, with easy-to-interpret results that will affect the diagnosis and triage of patients with suspected UGIB. (Clinical trial registration number: NCT05385224.)
AB - Background and Aims: Upper GI bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality. Timely EGD can be challenging from personnel, resource, and access perspectives. PillSense (EnteraSense Ltd, Galway, Ireland) is a novel swallowed bleeding sensor for the detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB. Methods: This prospective, open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB was 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 for 21 days to confirm capsule passage. Results: A total of 126 patients were accrued to the study (59.5% male; mean age, 62.4 ± 14.3 years). Sensitivity and specificity for detecting the presence of blood were 92.9% (P = .02) and 90.6% (P < .001), respectively. The capsule's positive and negative predictive values were 74.3% and 97.8%, and positive and negative likelihood ratios were 9.9 and .08. 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 before upper GI endoscopy. It is a rapidly deployed tool, with easy-to-interpret results that will affect the diagnosis and triage of patients with suspected UGIB. (Clinical trial registration number: NCT05385224.)
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U2 - 10.1016/j.gie.2023.11.051
DO - 10.1016/j.gie.2023.11.051
M3 - Article
C2 - 38065512
AN - SCOPUS:85189106624
SN - 0016-5107
VL - 99
SP - 712
EP - 720
JO - Gastrointestinal endoscopy
JF - Gastrointestinal endoscopy
IS - 5
ER -