A Study of the Influence of Central Obesity on the Esophageal Epithelial Barrier
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Rochester, Minnesota: 16-001069
NCT ID: NCT02776982
Sponsor Protocol Number: 16-001069
About this study
This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).
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
- Is undergoing clinically indicated 24-hour ambulatory impedance pH monitoring (off reflux medications for 7 days) in the Esophageal Function Laboratory at Mayo Clinic, followed by endoscopy within 24-96 hours
Exclusion Criteria
- Pre-existing or suspected Barrett's Esophagus (> 1cm of columnar mucosa in esophagus on endoscopy
- Oral anticoagulation precluding endoscopic biopsies
- Known hypersensitivity to fluorescein sodium
- Nickel/metal allergies
- Pacemaker
- Scheduled for an MRI within 30 days after Bravo placement
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Prasad Iyer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available