NCT01384227
Completed
Early Phase 1
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Anandasabapathy, Sharmila, M.D.1 site in 1 country40 target enrollmentFebruary 2009
Overview
- Phase
- Early Phase 1
- Intervention
- Proflavine Hemisulfate
- Conditions
- Barrett's Esophagus
- Sponsor
- Anandasabapathy, Sharmila, M.D.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To determine whether tissue is neoplastic or non-neoplastic
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Sharmila Anandasabapathy, MD
Associate Professor of Medicne
Anandasabapathy, Sharmila, M.D.
Eligibility 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
Arms & Interventions
Proflavine Hemisulfate
Intervention: Proflavine Hemisulfate
Outcomes
Primary Outcomes
To determine whether tissue is neoplastic or non-neoplastic
Time Frame: 1 day
Study Sites (1)
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