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

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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mount Sinai Medical Center

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proflavine Hemisulfate

Drug

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

Other names: Proflavine

Primary outcomes

To determine whether tissue is neoplastic or non-neoplastic

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Anandasabapathy, Sharmila, M.D.

Indiv

Collaborators

Icahn School of Medicine at Mount Sinai

Registry information

Important dates

Study start: 2009
Primary completion: 2011
First posted: Jun 29, 2011
Registry last updated: Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed