NCT03228407

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: McGuire Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Conditions

• Gastro Esophageal Reflux
• Barrett Esophagus
• Erosive Esophagitis

Interventions

Type	Name	Description
PROCEDURE	Confocal endomicroscopy	Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
DIAGNOSTIC_TEST	Endoscopic biopsies	Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
DIAGNOSTIC_TEST	Mucosal impedance (MI)	MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.

Timeline

• Start date: 2017-04-28
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2017-07-24
• Last updated: 2018-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study