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Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

NCT00795184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-05-03

Study results available
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Summary

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Conditions

  • Barrett Syndrome
  • Barrett's Syndrome
  • Barrett's Esophagus
  • Barrett Esophagus
  • Adenocarcinoma

Interventions

DEVICE

Imaging procedures (NBI)

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

DEVICE

HDWLE

DEVICE

pCLE

Sponsors & Collaborators

  • Cellvizio Inc.

    collaborator INDUSTRY

  • Emissary International LLC

    collaborator INDUSTRY

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Prateek Sharma, MD · Veterans Affairs Hospital, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-09-30
Completion
2010-02-28

Countries

  • United States
  • France
  • Germany

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 NCT00795184 on ClinicalTrials.gov