A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anandasabapathy, Sharmila, M.D.
• Treatments: Proflavine

Criteria

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