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Pilot Study for Imaging of the Esophagus Using an OFDI Capsule
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
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 operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
February 1, 2012
Primary Completion Date
July 31, 2015
Completion Date
July 1, 2016
Last Updated
April 30, 2019
56
ACTUAL participants
OFDI Capsule
DEVICE
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT06693531
NCT05199532
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06596252