Functional Dyspepsia Clinical Trial
Official title:
Reproducibility and Inter-Reader Reliability of Electrogastrographic Readings in Normal Subjects and Dyspeptic Patients
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.
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.
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