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Brief Title: Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Official Title: Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Study ID: NCT02947971
Brief Summary: The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Detailed Description: Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study. The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis. Images of the esophagus will be acquired in real time to be analyzed later.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Massachusetts General hospital, Boston, Massachusetts, United States
Name: Guillermo Tearney, MD, PhD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR