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A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01262937
First received: December 14, 2010
Last updated: December 17, 2010
Last verified: December 2010
History of Changes

December 14, 2010
December 17, 2010
July 2009
December 2012   (final data collection date for primary outcome measure)
To compare confocal image characteristics between benign and malignant tissue. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262937 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Digestive System Diseases
Device: Confocal Imaging
Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)
  • Experimental: Biliary Confocal Imaging
    Intervention: Device: Confocal Imaging
  • Experimental: Esophageal Confocal Imaging
    Intervention: Device: Confocal Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
  • Patients undergoing ERCP for known or suspected biliary strictures.

Exclusion Criteria:

  • have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
  • are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
  • are pregnant or breastfeeding
  • patients with advanced esophageal cancer
  • acute gastrointestinal bleeding
  • coagulopathy
  • impaired renal function
Both
18 Years and older
No
Contact: Michael Nathanson, MD, PhD 203-785-7312 michael.nathanson@yale.edu
United States
 
NCT01262937
0706002810
No
Michael Nathanson, Yale University
Yale University
Not Provided
Principal Investigator: Michael Nathanson, MD, PhD Yale University
Yale University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP