CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia (CLEAN-MARGIN)

March 22, 2016 updated by: Mauna Kea Technologies

Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Centre Hospitalier Universitaire
  • United Kingdom
      • London, United Kingdom
        • University College London Hospital
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Hospital
    • Washington
      • Seattle, Washington, United States, 98115
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
  • Undergoing any type of endoscopic BE ablation treatment
  • <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
  • Age > 18 years
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Participation in another clinical study
  • Circumferential BE
  • Complete eradication of BE documented by biopsies
  • Inability to obtain biopsies due to anticoagulation, varices, etc.
  • Allergy to fluorescein
  • Pregnancy
  • Renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard endoscopic evaluation
Standard high-definition white light endoscopy guided evaluation
Device: Standard endoscopic evaluation
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
Experimental: pCLE-guided evaluation
Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Time Frame: 3 month follow-up endoscopic procedure
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
3 month follow-up endoscopic procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauna Kea Technologies

Collaborators

Cellvizio Inc.

Investigators

  • Principal Investigator: Michael Wallace, MD, Mayo Clinic Jacksonville, Florida, United States
  • Study Director: Anne Osdoit, Mauna Kea Technologies, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKT-2009-BE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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