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

Digestive System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262937
• Other study ID #: 0706002810
• Status: Terminated
• Phase: N/A
• First received: December 14, 2010
• Last updated: February 21, 2018
• Start date: July 2009
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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)

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare confocal image characteristics between benign and malignant tissue.		2 Years