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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01384227

Enrollment

Registered

2011-06-29

Start date

2009-02-28

Completion date

Unknown

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagus, in vivo imaging, image guide microscope

Brief summary

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.

Interventions

DRUGProflavine Hemisulfate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine whether tissue is neoplastic or non-neoplastic	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026