Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

Early Phase 1CompletedNCT01384227

Anandasabapathy, Sharmila, M.D.40 enrolled

Overview

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Barrett's Esophagus

Interventions

Proflavine HemisulfateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Barrett's without dysplasia * Barrett's with dysplasia * Esophageal Adenocarcinoma Exclusion Criteria: * Subjects unfit for standard upper endoscopy * Subjects currently receiving chemo or radiation treatment * Subject currently receiving PDT or ablation

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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