Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Early Phase 1
Terminated
- Conditions
- Colonic DysplasiaColon PolypsAnal Dysplasia
- Interventions
- Registration Number
- NCT01384240
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 183
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proflavine Hemisulfate Proflavine Hemisulfate -
- Primary Outcome Measures
Name Time Method to determine whether tissue in nepoplastic 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