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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anandasabapathy, Sharmila, M.D.
• Collaborator: Icahn School of Medicine at Mount Sinai
• Treatments: Proflavine

Criteria

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