An interventional study of Confocal endomicroscopy and Mucosal impedance in Gastroesophageal Reflux and GERD, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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).
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 38 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who are undergoing clinically indicated upper endoscopy with Bravo ambulatory pH capsule (off reflux medications for 7 days), in the Esophageal Clinic at Mayo Clinic.
Exclusion Criteria:
Participants enrolled in study will have confocal endomicroscopy, research biopsies, mucosal impedance, and Bravo ambulatory pH capsule performed at the time of clinically indicated endoscopy.
Procedure: Confocal endomicroscopy · Procedure: Mucosal impedance · Procedure: Research biopsies · Procedure: Bravo ambulatory pH monitor
Confocal endomicroscopy will be performed during clinically indicated endoscopy.
Mucosal impedance will be performed at the time of clinically indicated endoscopy.
Research biopsies will be obtained during clinically indicated endoscopy.
Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.
Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.
Time frame: One year
Compare paracellular permeability of esophageal squamous epithelium by measuring mucosal impedance and IV fluorescein leak using a confocal laser endomicroscope in those patients with/without gastroesophageal reflux and with/without central obesity.
Time frame: One year
Compare the prostaglandin E2 level as measured by enzyme immunoassay in esophageal squamous epithelium in those patients with/without gastroesophageal reflux and with/without central obesity.
Time frame: One year
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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