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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Proflavine Hemisulfate

Group Type EXPERIMENTAL

Proflavine Hemisulfate

Intervention Type DRUG

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

Interventions

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Proflavine Hemisulfate

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

Intervention Type DRUG

Other Intervention Names

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Proflavine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No