A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Phase 0
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
GERD, Barrett's Esophagus
Both
GERD, Barrett's Esophagus
Trial Information
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Inclusion Criteria:
- patient 18 years or older
- colonoscopy for screening or surveillance of polyps or disease of colon
- anoscopy because of suspected or known anal dysplasia or neoplasia
Exclusion Criteria:
- patient unable to provide informed consent
- patient found unfit for standard colonoscopy or anoscopy with biopsies
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel 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# 09-0696 Project 1
NCT ID:
NCT01384695
Start Date:
June 2009
Completion Date:
December 2015
Related Keywords:
- GERD
- Barrett's Esophagus
- Barrett's esophagus
- confocal microendoscopy
- Barrett Esophagus
- Neoplasms
Name | Location |
|---|---|
| Mount Sinai Medical Center | New York, New York 10029 |
