- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262937
A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
February 21, 2018 updated by: Yale University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale New Haven Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia.
Also, patients undergoing ERCP for known or suspected biliary strictures.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Biliary 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)
|
Esophageal 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare confocal image characteristics between benign and malignant tissue.
Time Frame: 2 Years
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Nathanson, MD, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
December 14, 2010
First Submitted That Met QC Criteria
December 17, 2010
First Posted (Estimate)
December 20, 2010
Study Record Updates
Last Update Posted (Actual)
February 26, 2018
Last Update Submitted That Met QC Criteria
February 21, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0706002810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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