Study to Image the Esophagus Using the OFDI Capsule

N/ACompletedNCT02204150

Massachusetts General Hospital56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Barrett's Esophagus Eosinophilic Esophagitis

Interventions

OFDI CapsuleDEVICE

Imaging of the esophagus using the OFDI Capsule and system

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * Subjects with known esophageal strictures, intestinal strictures or dysphagia * OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule

Number of subjects from whom the quality OFDI imaging was obtained

Time frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Data from ClinicalTrials.gov

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