Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2012-02-29
2016-07-31
Brief Summary
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Detailed Description
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As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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OFDI Capsule Imaging
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.
OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
Interventions
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OFDI Capsule
Imaging of the esophagus using the OFDI Capsule and system
Eligibility Criteria
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Inclusion Criteria
* OR a previous diagnosis of EoE
* OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
* Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
* Subject must be able to give informed consent
Exclusion Criteria
* OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
16 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Guillermo Tearney
Principal Investigator
Principal Investigators
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Guillermo Tearney, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2011P002619
Identifier Type: -
Identifier Source: org_study_id
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