A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

Early Phase 1TerminatedNCT01384695

Anandasabapathy, Sharmila, M.D.67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

GERD Barrett's Esophagus

Interventions

fluorescent contrast agent, Fluorescein 5ml

Proflavine hemisulfateDRUG

3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

to determine whether tissue is neoplastic or non-neoplastic

Time frame: 1 day

Data from ClinicalTrials.gov

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