Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Overview
- Phase
- Early Phase 1
- Intervention
- Proflavine Hemisulfate
- Conditions
- Colon Polyps
- Sponsor
- Anandasabapathy, Sharmila, M.D.
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- to determine whether tissue in nepoplastic or non-neoplastic
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •surveillance of polyps or disease of the colon
- •screening colonoscopy
- •anoscopy for suspected or known anal dysplasia or neoplasia
Exclusion Criteria
- •unfit for standard colonoscopy or anoscopy
- •unable to provide informed consent
Arms & Interventions
Proflavine Hemisulfate
Intervention: Proflavine Hemisulfate
Outcomes
Primary Outcomes
to determine whether tissue in nepoplastic or non-neoplastic
Time Frame: 1 day