NCT00128284

A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time

A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: The SmartPill Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Diseases
• Stomach Diseases
• Gastroparesis

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-08-09
• Last updated: 2008-05-22

Locations

7 sites across 1 country: United States