The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.
Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available. Accurate characterization of gastric emptying may guide medical and surgical treatment choices. In addition, these techniques may allow for monitoring of therapeutic results for follow-up patient management. The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 65 years of age and older.
Study Type
OBSERVATIONAL
Enrollment
23
Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis.
Time frame: 30 minute intervals up to 6 hours
To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis
Time frame: Continuous time measure until capsule elimination
To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis
Time frame: Continuous time measure until capsule elimination
To characterize total GI transit time in healthy subjects
Time frame: Continuous time measure until capsule elimination
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