Barrett Esophagus Clinical Trial
Official title:
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy, - Patients over the age of 18 - Patients who are capable of giving informed consent - Patients who had or will have a standard of care EGD within 9 to 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: - Patients with prior endoscopic ablation or resection treatment of BE - Patients with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule - Patients with the inability to swallow capsules. - Pregnancy, according to patient information |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy | An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. They will assess how the images change over time. | Approximate 25 minutes visit (10 min image acquisition) |
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