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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00220883
First received: September 19, 2005
Last updated: February 6, 2006
Last verified: September 2005
  Purpose

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.


Condition
Functional Dyspepsia

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Reproducibility and Inter-Reader Reliability of Electrogastrographic Readings in Normal Subjects and Dyspeptic Patients

Resource links provided by NLM:


Further study details as provided by Temple University:

Estimated Enrollment: 40
Study Start Date: August 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220883

Contacts
Contact: Henry P Parkman, MD 1-215-707-7579 henry.parkman@temple.edu

Locations
United States, Pennsylvania
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P. Parkman, MD    215-707-3431    henry.parkman@temple.edu   
Principal Investigator: Henry P. Parkman, MD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Henry P Parkman, MD Temple University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220883     History of Changes
Other Study ID Numbers: TU4687
Study First Received: September 19, 2005
Last Updated: February 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Functional Dyspepsia
Electrogastrography

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 11, 2014