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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
  Purpose

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.


Condition Intervention
Digestive System Diseases
 Device: Confocal Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • To compare confocal image characteristics between benign and malignant tissue. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biliary Confocal Imaging 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: Esophageal Confocal Imaging 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262937

Contacts
Contact: Michael Nathanson, MD, PhD 203-785-7312 michael.nathanson@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Michael Nathanson            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Michael Nathanson, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Michael Nathanson, Yale University
ClinicalTrials.gov Identifier: NCT01262937     History of Changes
Other Study ID Numbers: 0706002810
Study First Received: December 14, 2010
Last Updated: December 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
confocal, biliary, esophagus

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013