A Study to Evaluate the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-008065
NCT ID: NCT02994693
Sponsor Protocol Number: 2016P000919
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with known Barrett’s Esophagus (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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Michael Wallace, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available