Clin Endosc.  2024 Jan;57(1):73-81. 10.5946/ce.2022.293.

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

• Schuster KF
• Thompson CC
• Ryou M

• KMID: 2551195
• DOI: http://doi.org/10.5946/ce.2022.293

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.

Keyword

Animals; Biosensing techniques; Disease models, animal; Endoscopy, gastrointestinal; Gastrointestinal hemorrhage/diagnosis

Figure

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  Fig. 1. PillSense System components. (A) PillSense capsule and (B) receiver. The PillSense System’s wireless communication system, consisting of internal optical sensors (A), links wirelessly to the external receiver and can relay data (B).

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  Fig. 2. Blood detection results in the acute study. The graph demonstrates increasing PillSense System sensor output as a function of increasing blood concentration in the stomach.

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  Fig. 3. Sensor output values recorded during survival study. All 12 sensors in the survival study detected a minimum blood concentration of 9%. There was a significant difference between the outputs of the sensor in the absence and presence of blood.

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