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Pavel Drastich 1 Article
Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial
Lukas Bajer, Marvin Ryou, Christopher C. Thompson, Pavel Drastich
Clin Endosc 2024;57(2):203-208.   Published online January 17, 2024
DOI: https://doi.org/10.5946/ce.2023.111
Graphical AbstractGraphical Abstract AbstractAbstract PDFPubReaderePub
Background
/Aims: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization, and can be diagnosed by direct visualization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers.
Methods
In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events.
Results
The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased from 2.8 to 4, indicating that each camera detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported.
Conclusions
The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

Citations

Citations to this article as recorded by  
  • Could a bleeding-sensor device be established as a new paradigm for detecting upper gastrointestinal bleeding before performing endoscopy?
    Sun Gyo Lim
    Clinical Endoscopy.2024; 57(2): 191.     CrossRef
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  • 1 Crossref
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