• Peter J van der Schaar, J Frits Dijksman, Henny Broekhuizen-de Gast, Jeff Shimizu, Niels van Lelyveld, Hans Zou, Ventzeslav Iordanov, Christoph Wanke, and Peter D Siersema.
• Department of Gastroenterology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands.
• Gastrointest. Endosc. 2013 Sep 1; 78 (3): 520-8.

BackgroundWe developed an ingestible electronic drug delivery and monitoring system. This system includes an electronic capsule comprising a drug reservoir, a pH and temperature sensor, a microprocessor and wireless transceiver, a stepper motor, and batteries. The location of the capsule in the gut derived from pH data can be monitored in real time. The stepper motor can be remotely actuated to expel the contents of the drug reservoir.ObjectivesFirst human study.DesignTwo consecutive observational studies.SettingUniversity medical center.SubjectsTwenty healthy volunteers.InterventionsStudy I: Ingestion and passage of the capsule. Study II: Ingestion and passage of the capsule, loaded with (99m)technetium-pertechnetate ((99m)Tc); remotely actuated expulsion of (99m)Tc in the gut.Main Outcome MeasurementsStudy I: Safety, tolerability, and functionality (wireless pH and temperature recording). Study II: Tracing of the capsule and expulsion and distribution of (99m)Tc from the drug reservoir by scintigraphy. Correlating location pH with scintigraphy.ResultsStudy I: Ingestion and passage of the capsule was safe and well tolerated. Transmitted pH and temperature data were received by the recorder in 96.5% ± 3%. Study II: pH-determined passage of the esophagogastric, gastroduodenal, and ileocolonic junction correlated well with scintigraphy. Expulsion of (99m)Tc from the capsule was successful in 9 of 10 subjects.LimitationsSubjects with relatively low body mass index.ConclusionsThis electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

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