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

NCT03228407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-01-16

No results posted yet for this study

Summary

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

Conditions

  • Gastro Esophageal Reflux
  • Barrett Esophagus
  • Erosive Esophagitis

Interventions

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 The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth.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 After MI measurements are obtained, the balloon will be deflated and withdrawn.

Sponsors & Collaborators

  • Hunter Holmes McGuire VA Medical Center

    collaborator FED

  • McGuire Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228407 on ClinicalTrials.gov