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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01032044
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Cellvizio Inc.
Information provided by (Responsible Party):
Mauna Kea Technologies

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Barrett Syndrome Barrett's Syndrome Barrett's Esophagus Barrett Esophagus Adenocarcinoma Device: Standard endoscopic evaluation Device: pCLE guided evaluation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Study Start Date : February 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032044


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States, 60637
United States, Missouri
Veterans Affairs Hospital
Kansas City, Missouri, United States, 64128
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98115
France
Centre Hospitalier Universitaire
Nantes, France
United Kingdom
University College London Hospital
London, United Kingdom
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Investigators
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Principal Investigator: Michael Wallace, MD Mayo Clinic Jacksonville, Florida, United States
Study Director: Anne Osdoit Mauna Kea Technologies, Paris, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT01032044    
Other Study ID Numbers: MKT-2009-BE-01
First Posted: December 15, 2009    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: March 2016
Keywords provided by Mauna Kea Technologies:
Barrett's esophagus
EsoGastroDuodenoscopy
Barrett's carcinoma
adenocarcinoma
Cellvizio
endomicroscopy
 probe-based Confocal Laser Endomicroscopy
pCLE
Radio-frequency ablation
Endoscopic mucosal resection
Photodynamic therapy
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Barrett Esophagus
Syndrome
Disease
Pathologic Processes
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases