Barrett Esophagus
Conditions
Keywords
Barrett's Esophagus, Natural History, Capsule, OCT, Tethered Capsule Endomicroscopy
Brief summary
The goal of this research is to follow Barrett's Esophagus participants 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
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 participants diagnosed with Barrett's Esophagus and undergoing surveillance endoscopy.
Interventions
DEVICETethered Capsule Endomicroscopy (TCE)
Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus
Sponsors
Columbia University
Mayo Clinic
Kansas City Veteran Affairs Medical Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
100 participants are enrolled in year 1 in each of five participating centers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants over the age of 18 * Participants who are capable of giving informed consent * Participants with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy * Participants who had or will have a standard of care EGD within 15 months, exceptions to this can be submitted to the coordinating center (MGH) for approval
Exclusion criteria
* Participants with prior endoscopic ablation or resection treatment of BE at enrollment visit * Participants with esophageal fistula and/or esophageal strictures * Participants with the inability to swallow capsules * Concomitant chemotherapy treatment * Self reported pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy | 4 years | We will be measuring the size of the area affected by Barrett's. |
Countries
United States
Outcome results
None listed