Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220883
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2005-09-19
Brief Title:
Electrogastrogram EGG Reproducibility Study EEG Readings in Normal Subjects and Dyspeptic Patients
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Reproducibility and Inter-Reader Reliability of Electrogastrographic Readings in Normal Subjects and Dyspeptic Patients
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 subjectpatient 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 normalhealthy 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
Each study subjectpatient 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 normalhealthy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None