Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?
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|ClinicalTrials.gov Identifier: NCT01204931|
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : January 20, 2016
|Condition or disease|
|Gastroesophageal Reflux Disease|
|Study Type :||Observational|
|Actual Enrollment :||254 participants|
|Observational Model:||Case Control|
|Official Title:||Can We Predict Who Has GERD? Systematic Evaluation of Role of pH Monitoring and the Specific Physiologic pH Parameters in Defining GERD, Bravo, Impedence and SISAP|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||June 2015|
Gastroesophageal Reflux Disease (GERD) Cases
Erosive disease - presence of esophageal mucosal injuries documented endoscopically.
Non-erosive disease - normal esophagogastroduodenoscopy with symptoms
normal subjects without symptoms of gastroesophageal reflux disease (GERD)
- Symptom Index (SI) and Symptom Associated Probability (SAP) [ Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring ]Assess the sensitivity and specificity of symptom association indices (SI and SAP)regarding gastroesophageal reflux disease (GERD)
- Predicting gastroesophageal reflux disease (GERD) [ Time Frame: Following esophagogastroduodenoscopy (EGD) and 48-hr-wireless pH monitoring ]Determine the best parameter for predicting gastroesophageal reflux disease (GERD) from a list of conventional pH measurement findings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204931
|United States, Tennessee|
|Vanderbilt University Medical Center GI Outpatient Clinic|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Michael Vaezi, MD, PhD||Vanderbilt University Medical Center|