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Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

NCT02018367 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-14

No results posted yet for this study

Summary

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Conditions

  • Barrett's Esophagus

Interventions

DRUG

Proflavine, high resolution imaging

5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Anandasabapathy, Sharmila, M.D.

    lead INDIV

Principal Investigators

  • Sharmila Anandasabapathy, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2021-12-31
Completion
2021-12-31

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 NCT02018367 on ClinicalTrials.gov