Back to resultsA Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Primary Purpose
GERD, Barrett's Esophagus
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluorescein
Proflavine hemisulfate
Sponsored by
About this trial
This is an interventional screening trial for GERD focused on measuring Barrett's esophagus, confocal microendoscopy
Eligibility Criteria
Inclusion Criteria:
- patient 18 years or older
- colonoscopy for screening or surveillance of polyps or disease of colon
- anoscopy because of suspected or known anal dysplasia or neoplasia
Exclusion Criteria:
- patient unable to provide informed consent
- patient found unfit for standard colonoscopy or anoscopy with biopsies
Sites / Locations
- Mount Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fluorescein
Proflavine hemisulfate
Arm Description
Confocal imaging using contrast agent fluorescein
confocal imaging using contrast agent proflavine
Outcomes
Primary Outcome Measures
to determine whether tissue is neoplastic or non-neoplastic
Secondary Outcome Measures
Full Information
NCT ID
NCT01384695
First Posted
June 28, 2011
Last Updated
January 8, 2016
Sponsor
Anandasabapathy, Sharmila, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01384695
Brief Title
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Official Title
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Low/no enrollment. No subjects were enrolled over the past year.
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anandasabapathy, Sharmila, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD, Barrett's Esophagus
Keywords
Barrett's esophagus, confocal microendoscopy
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluorescein
Arm Type
Experimental
Arm Description
Confocal imaging using contrast agent fluorescein
Arm Title
Proflavine hemisulfate
Arm Type
Experimental
Arm Description
confocal imaging using contrast agent proflavine
Intervention Type
Drug
Intervention Name(s)
Fluorescein
Intervention Description
fluorescent contrast agent, Fluorescein 5ml
Intervention Type
Drug
Intervention Name(s)
Proflavine hemisulfate
Other Intervention Name(s)
Proflavine
Intervention Description
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Primary Outcome Measure Information:
Title
to determine whether tissue is neoplastic or non-neoplastic
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient 18 years or older
colonoscopy for screening or surveillance of polyps or disease of colon
anoscopy because of suspected or known anal dysplasia or neoplasia
Exclusion Criteria:
patient unable to provide informed consent
patient found unfit for standard colonoscopy or anoscopy with biopsies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharmila Anandasabapathy, M.D.
Organizational Affiliation
Mt. Sinai School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
We'll reach out to this number within 24 hrs