A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - Over 65 Years Old (GETOver65)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To characterize total GI transit time in healthy subjects [ Time Frame: Continuous time measure until capsule elimination ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
healthy adult subjects with no history or current gastrointestinal disorders or conditions
Subjects with documented gastroparesis
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.
|United States, Kansas|
|Division of Gastroenterology and Hepatology at KUMC|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Braden Kuo, MD||Massachusetts General Hospital|
|Study Director:||John R Semler, PhD||SmartPill Corporation|