- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943280
Barrett's Esophagus in Olmsted County
Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study
To compare participation rates in screening for Barrett's Esophagus (BE) using sedated esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. An age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from Olmsted County11, 12 using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR conventional sedated endoscopy. The investigators will compare participation rates in the three arms.
To identify factors associated with non-participation in population screening for BE. The investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated Gastroesophageal Reflux questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by all targeted subjects. This preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Olmsted county resident
Exclusion Criteria:
- History of known BE or endoscopy within the last 5 years;
- History of progressive dysphagia;
- Known Zenker's diverticulum;
- Known epiphrenic diverticulum;
- Known or suspected intestinal obstruction;
- Cardiac pacemakers or other implanted electro-medical devices;
- Pregnancy;
- Patient expected to undergo MRI examination within 7 days after ingestion of the capsule;
- History of prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy) within the last six months; pregnancy;
- History of recurrent epistaxis, moved from Olmsted County or deceased;
- Significant illnesses that might impair ability to complete questionnaires (e.g. metastatic cancer, major stroke); and
- Any contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel [Plavix]).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1 EGD
Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to EGD.
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2 Transnasal
Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to Transnasal endoscopy.
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3 PillCam
Olmsted county residents with no history of Barrett's esophagus,who have previously completed GERQ questionnaire, randomized to PillCam.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The primary outcome variable for this aim will be the number of subjects in each group that need to be contacted until 20 in each group agree to participate in this study.
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ganapathy A. Prasad, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-003642
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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