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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01262937
First received: December 14, 2010
Last updated: March 8, 2017
Last verified: March 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

Resource links provided by NLM:


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 ]

Enrollment: 106
Actual Study Start Date: July 2009
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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)

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01262937

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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01262937     History of Changes
Other Study ID Numbers: 0706002810
Study First Received: December 14, 2010
Last Updated: March 8, 2017

Keywords provided by Yale University:
confocal, biliary, esophagus

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on March 22, 2017