title: A novel ingestible electronic drug delivery and monitoring device.
abstract: 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.
  
  
  OBJECTIVE
  First human study.
  
  
  METHODS
  Two consecutive observational studies.
  
  
  METHODS
  University medical center.
  
  
  METHODS
  Twenty healthy volunteers.
  
  
  METHODS
  Study 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.
  
  
  METHODS
  Study 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.
  
  
  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 of (99m)Tc from the capsule was successful in 9 of 10 subjects.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: van der Schaar
authors.forename: J Frits
authors.initials: JF
authors.lastname: Dijksman
authors.forename: Henny
authors.initials: H
authors.lastname: Broekhuizen-de Gast
authors.forename: Jeff
authors.initials: J
authors.lastname: Shimizu
authors.forename: Niels
authors.initials: N
authors.lastname: van Lelyveld
authors.forename: Hans
authors.initials: H
authors.lastname: Zou
authors.forename: Ventzeslav
authors.initials: V
authors.lastname: Iordanov
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanke
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
mesh_terms: D000328:Adult; D001831:Body Temperature; D002214:Capsules / Q000009:adverse effects; D016503:Drug Delivery Systems / Q000009:adverse effects / Q000295:instrumentation*; D055615:Electrical Equipment and Supplies / Q000009:adverse effects; D005260:Female; D041981:Gastrointestinal Tract / Q000000981:diagnostic imaging; D005772:Gastrointestinal Transit; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008838:Microcomputers; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D011877:Radionuclide Imaging; D013667:Technetium / Q000008:administration & dosage; D013686:Telemetry; D013997:Time Factors; D059015:Wireless Technology; D055815:Young Adult
chemical_list: D002214:Capsules; D013667:Technetium
keywords: (99m)Tc; (99m)technetium-pertechnetate