Preclinical study of a novel ingestible bleeding sensor for upper gastrointestinal bleeding

Abstract

Background/Aims: Upper gastrointestinal bleeding (UGIB) is a life-threatening condition that necessitates early identification and intervention and is associated with substantial morbidity, mortality, and socioeconomic burden. However, several diagnostic challenges remain regarding risk stratification and the optimal timing of endoscopy. The PillSense System is a noninvasive device developed to detect blood in patients with UGIB in real time. This study aimed to assess the safety and performance characteristics of PillSense using a simulated bleeding model.Methods: A preclinical study was performed using an in vivo porcine model (14 animals). Fourteen PillSense capsules were endoscopically placed in the stomach and blood was injected into the stomach to simulate bleeding. The safety and sensitivity of blood detection and pill excretion were also investigated.Results: All the sensors successfully detected the presence or absence of blood. The minimum threshold was 9% blood concentration, with additional detection of increasing concentrations of up to 22.5% blood. All the sensors passed naturally through the gastrointestinal tract.Conclusions: This study demonstrated the ability of the PillSense System sensor to detect UGIB across a wide range of blood concentrations. This ingestible device detects UGIB in real time and has the potential to be an effective tool to supplement the current standard of care. These favorable results will be further investigated in future clinical studies.

Miniaturized Capsule System Toward Real‐Time Electrochemical Detection of H2S in the Gastrointestinal Tract

“…Ingestible capsules of varied size and function, employed in vivo for testing in porcine studies, are summarized in Table S2 (Supporting Information). [25,[63][64][65][66][67][68][69][70][71][72][73] The main limiting factors for further scaling the H 2 S sensing capsule are the size of the COTS electronic components and compatibility of the battery chemistry. Bluetooth LE has an instantaneous current consumption of ≈10 mA (at +0 dB antenna gain), which prevents the use of alternative safe battery chemistries, such as silver oxide (Ø = 9.5 mm), without greatly reducing the wireless transmission rate (10 s).…”