Sie befinden Sich nicht im Netzwerk der Universität Paderborn. Der Zugriff auf elektronische Ressourcen ist gegebenenfalls nur via VPN oder Shibboleth (DFN-AAI) möglich. mehr Informationen...
Background We 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. Objectives First human study. Design Two consecutive observational studies. Setting University medical center. Subjects Twenty healthy volunteers. Interventions Study I: Ingestion and passage of the capsule. Study II: Ingestion and passage of the capsule, loaded with99m technetium-pertechnetate (99m Tc); remotely actuated expulsion of99m Tc in the gut. Main Outcome Measurements Study I: Safety, tolerability, and functionality (wireless pH and temperature recording). Study II: Tracing of the capsule and expulsion and distribution of99m Tc from the drug reservoir by scintigraphy. Correlating location pH with scintigraphy. Results Study 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 of99m Tc from the capsule was successful in 9 of 10 subjects. Limitations Subjects with relatively low body mass index. Conclusions This electronic drug delivery and monitoring system may be a promising tool for targeted delivery of substances to well-defined areas of the GI tract.