Trials / Completed
CompletedNCT01384227
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Anandasabapathy, Sharmila, M.D. · Individual
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Proflavine Hemisulfate | Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water) |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-07-01
- First posted
- 2011-06-29
- Last updated
- 2016-01-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01384227. Inclusion in this directory is not an endorsement.