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CompletedNCT00220883Updated Aug 17, 2020

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

An observational study in Functional Dyspepsia, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 18 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-17.

Sponsored by Temple University · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 72 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Functional Dyspepsia

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Keywords

  • Functional Dyspepsia
  • Electrogastrography
03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's planned enrollment of 40 is below the median of 192 across 56 observational studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

For normal healthy subjects:

Inclusion Criteria:

  1. Male or female patients who are 18 years of age to 72 years of age.
  2. Normal healthy subjects with no signs or symptoms of gastrointestinal discomfort.

Exclusion Criteria:

Patients will not be included in this study if they are:

  1. \< 18 years of age or >72 years of age
  2. Subjects with known gastrointestinal or liver cancers, pancreaticobiliary tract diseases, active peptic ulcer disease or uncontrolled lactose intolerance.
  3. Subjects with cardiovascular, pulmonary disorders, or subjects with diabetes mellitus, a malignancy or who are known to be HIV positive.
  4. Subjects with a history of gastric, intestinal or colonic resections. Subjects who are at less than a three month status for either: post appendectomy, cholecystectomy, or hysterectomy with or without oophorectomy.
  5. Subjects who are unable to give informed consent or adequately express their subjective complaints.
  6. Subjects who abuse drugs or alcohol.
  7. Female subjects who are pregnant.

For functional dyspepsia patients:

Inclusion Criteria:

  1. Male or female patients who are 18 to 72 years of age.
  2. Patients who present with varying gastric complaints of discomfort
  3. Patients who meet all Rome II criteria for functional dyspepsia (see Rome II criteria checklist)

Concomitant medications are allowed during the study period.

05

Study design

Time perspective
Prospective
Enrollment
40 participants (estimated)
06

Study locations

1 site
  • Temple University School of Medicine
    Philadelphia, Pennsylvania 19140, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00220883
Lead sponsor
Temple University
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Aug 2005
Primary completion
Aug 2006
Completion
Sep 2006
Last update
Aug 17, 2020

Study contacts

Henry P Parkman, MD
principal investigator · Temple University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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