Colon Polyps, Colonic Dysplasia, Anal Dysplasia
Conditions
Keywords
colon polyps, colonic dysplasia, anal dysplasia, microendoscopy
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.
Interventions
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
Sponsors
Anandasabapathy, Sharmila, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine whether tissue in nepoplastic or non-neoplastic | 1 day |
Countries
United States
Outcome results
None listed