NCT00220883

Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients

Reproducibility and Inter-Reader Reliability of Electrogastrographic Readings in Normal Subjects and Dyspeptic Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine whether EGG readings obtained from both normal subjects and dyspeptic patients are reproducible from one EGG recording to another on a different day. The secondary objective of this study is to determine whether the EGG readings are analyzed and diagnosed consistently when reviewed and compared by multiple blinded readers when the same tracing is reviewed.

Detailed description

This is a single-center study. The duration of this trial is estimated to be six months. A total of Forty (40) subjects will be recruited into this study. It will be two Groups; ten (10) normal healthy subjects will be recruited by poster advertisement and thirty (30) patients who either present to the Gastroenterology Department of Temple University Hospital with varying signs, symptoms or complaints of gastric discomfort, or who are scheduled to undergo an EGG test by their Gastroenterologist. Each study subject/patient will have a total of two (2) EGGs with Water load tests performed for this study. Each EGG exam will be performed approximately one (1) week of each other, but no more than 4 weeks apart, and will be read in a blinded fashion by three (3) separate independent readers, in order to see if the readings are consistent with the previous readings that were obtained, as well as, by the readers themselves (Inter-reader rater reliability). Each reader will be blinded to the subject status (normal/healthy or patient) and also to the specific test they are reading (initial exam \[Visit 1\], or follow-up exam 1 week after Visit 1 \[Visit 2\]). All EGG exam results will be coded in order to keep them blind.

Conditions

• Functional Dyspepsia

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-08-01
• Completion: 2006-09-01
• First posted: 2005-09-22
• Last updated: 2020-08-17

Locations

1 site across 1 country: United States