Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia (CLEAN-MARGIN)

This study has been completed.
Sponsor:
Collaborator:
Cellvizio Inc.
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01032044
First received: December 11, 2009
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 Intervention
Barrett Syndrome
Barrett's Syndrome
Barrett's Esophagus
Barrett Esophagus
Adenocarcinoma
Device: Standard endoscopic treatment of BE
Device: pCLE guided endoscopic treatment of BE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:
  • Composite outcome of "optimally treated" BE patients 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. [ Time Frame: 3 month follow-up endoscopic procedure ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment
Standard high-definition white light endoscopy guided treatment
Device: Standard endoscopic treatment of BE
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
Experimental: pCLE-guided treatment
Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy
Device: pCLE guided endoscopic treatment of BE
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032044

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States
United States, Missouri
Veterans Affairs Hospital
Kansas City, Missouri, United States
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States
France
Centre Hospitalier Universitaire
Nantes, France
United Kingdom
University College London Hospital
London, United Kingdom
Sponsors and Collaborators
Mauna Kea Technologies
Cellvizio Inc.
Investigators
Principal Investigator: Michael Wallace, MD Mayo Clinic Jacksonville, Florida, United States
Study Director: Anne Osdoit Mauna Kea Technologies, Paris, France
  More Information

No publications provided by Mauna Kea Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT01032044     History of Changes
Other Study ID Numbers: MKT-2009-BE-01
Study First Received: December 11, 2009
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board
France: Comité de Protection des Personnes
United Kingdom: Research Ethics Committee

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:
Adenocarcinoma
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014