Overview

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