Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Phase 0
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Barrett's Esophagus
Both
Barrett's Esophagus
Trial Information
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
To determine whether tissue is neoplastic or non-neoplastic
Outcome Time Frame:
1 day
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
GCO # 08-1190
NCT ID:
NCT01384227
Start Date:
February 2009
Completion Date:
Related Keywords:
- Barrett's Esophagus
- Barrett's esophagus
- in vivo imaging
- image guide microscope
- Barrett Esophagus
- Neoplasms
Name | Location |
|---|---|
| Mount Sinai Medical Center | New York, New York 10029 |
