Study Stopped
Low/no enrollment. No subjects were enrolled over the past year.
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2009
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
June 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJanuary 12, 2016
January 1, 2016
4.7 years
June 28, 2011
January 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to determine whether tissue is neoplastic or non-neoplastic
1 day
Study Arms (2)
Fluorescein
EXPERIMENTALConfocal imaging using contrast agent fluorescein
Proflavine hemisulfate
EXPERIMENTALconfocal imaging using contrast agent proflavine
Interventions
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patient unable to provide informed consent
- patient found unfit for standard colonoscopy or anoscopy with biopsies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Medical Center
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharmila Anandasabapathy, M.D.
Mt. Sinai School of Medicine
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
June 29, 2011
Study Start
June 1, 2009
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
January 12, 2016
Record last verified: 2016-01