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

Anandasabapathy, Sharmila, M.D.

Status and phase: Completed; Early Phase 1

Conditions: Barrett's Esophagus

Treatments: Drug: Proflavine Hemisulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01384227

GCO # 08-1190

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Proflavine Hemisulfate

Experimental group

Treatment:

Drug: Proflavine Hemisulfate