Gastroparesis Clinical Trial
Official title:
A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time - In Subjects Over 65 Years of Age
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.
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Observational Model: Case Control, Time Perspective: Prospective
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