Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

Study Overview
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Brief Summary
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The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Detailed Description
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The progression of Barrett's Esophagus will be studied over time using tethered capsule endomicroscopy imaging and will be performed at 5 different clinical centers in the US, namely: Massachusetts General Hospital (MGH),(MA), Mayo Clinic Jacksonville (FL), Mayo Clinic Rochester (MN), Columbia University Medical Center (NY), Kansas City VA Medical Center (MO). MGH will be the coordinating center of this multicenter study. Dr G. Tearney will serve as study Sponsor Investigator. The purpose of this study is to determine the natural history of Barrett's Esophagus using TCE in subjects diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.

Official Title
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Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Device: Tethered Capsule Endomicroscopy (TCE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over the age of 18 Subjects who are capable of giving informed consent Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy, Subjects who had or will have a standard of care EGD within 15 months Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure Exclusion Criteria: Subjects with prior endoscopic ablation or resection treatment of BE at enrollment visit Subjects with esophageal fistula and/or esophageal strictures Subjects with the inability to swallow capsules Self reported pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: A hundred patients are enrolled in year 1 in each of five participating centers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental OFDI capsule imaging<br>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system. Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule | Device: Tethered Capsule Endomicroscopy (TCE)<br>* Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus<br>* Other names: OFDI capsule imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy | We will be measuring the size of the area affected by Barrett's. The measurements will done in cm. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's Esophagus, Natural History, Capsule, OCT, Tethered Capsule Endomicroscopy