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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262937
First Posted: December 20, 2010
Last Update Posted: March 13, 2017
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.
Information provided by (Responsible Party):
Yale University
December 14, 2010
December 20, 2010
March 13, 2017
July 2009
July 2016   (Final data collection date for primary outcome measure)
To compare confocal image characteristics between benign and malignant tissue. [ Time Frame: 2 Years ]
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.
This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
 
Terminated
106
July 2016
July 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01262937
0706002810
No
Not Provided
Not Provided
Yale University
Yale University
Not Provided
Principal Investigator: Michael Nathanson, MD, PhD Yale University
Yale University
March 2017

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