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CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

NCT01032044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2016-04-22

Study results available
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Summary

This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Conditions

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

Interventions

DEVICE

Standard endoscopic evaluation

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

DEVICE

pCLE guided evaluation

Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.

Sponsors & Collaborators

  • Cellvizio Inc.

    collaborator INDUSTRY

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Michael Wallace, MD · Mayo Clinic Jacksonville, Florida, United States

  • Anne Osdoit · Mauna Kea Technologies, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States
  • France
  • United Kingdom

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 NCT01032044 on ClinicalTrials.gov