GERD, Barrett's Esophagus
Conditions
Keywords
Barrett's esophagus, confocal microendoscopy
Brief summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.
Interventions
DRUGFluorescein
fluorescent contrast agent, Fluorescein 5ml
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Sponsors
Anandasabapathy, Sharmila, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine whether tissue is neoplastic or non-neoplastic | 1 day |
Countries
United States
Outcome results
None listed