A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1
Early Phase 1
Terminated
- Conditions
- GERDBarrett's Esophagus
- Interventions
- Registration Number
- NCT01384695
- Lead Sponsor
- Anandasabapathy, Sharmila, M.D.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 67
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluorescein Proflavine hemisulfate Confocal imaging using contrast agent fluorescein Proflavine hemisulfate Fluorescein confocal imaging using contrast agent proflavine
- Primary Outcome Measures
Name Time Method to determine whether tissue is neoplastic or non-neoplastic 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center🇺🇸New York, New York, United States