Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

Stopped early · Early Phase 1

Conditions studied: Colon Polyps, Colonic Dysplasia, Anal Dysplasia

In brief

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.

Key facts

Study ID

NCT01384240

Run by

Anandasabapathy, Sharmila, M.D.

People needed

183

Starts

2010-04-01

Expected to finish

2014-05-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• surveillance of polyps or disease of the colon
• screening colonoscopy
• anoscopy for suspected or known anal dysplasia or neoplasia

You may not qualify if…

• unfit for standard colonoscopy or anoscopy
• unable to provide informed consent

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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