Status:
COMPLETED
Study to Image the Esophagus Using the OFDI Capsule
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Barrett's Esophagus
Eosinophilic Esophagitis
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Detailed Description
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule...
Eligibility Criteria
Inclusion
- A previous diagnosis of Barrett's Esophagus
- 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
- Subjects with known esophageal strictures, intestinal strictures or dysphagia
- OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02204150
Start Date
February 1 2012
End Date
July 1 2016
Last Update
April 30 2019
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114