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Active Not Recruiting
NCT02994693
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Conditions: Barrett Esophagus, Barretts Esophagus With Dysplasia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.
Eligibility Criteria
Inclusion Criteria:
* Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
* Participants over the age of 18
* Participants who are capable of giving informed consent
* Participants who had or will have a standard of care EGD within 9 to 15 months
* Participants 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:
* Participants with prior endoscopic ablation or resection treatment of BE
* Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
* Participants with the inability to swallow capsules.
* Pregnancy, according to participant information
* Thrombocytopenia, coagulopathy, previous bone marrow transplant
* History or diagnosis of leukemia
Source: ClinicalTrials.gov (NCT02994693). StuddyBuddy aggregates publicly available trial information.