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

Early Phase 1TerminatedNCT01384240

Anandasabapathy, Sharmila, M.D.183 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

183

Conditions

Colon Polyps Colonic Dysplasia Anal Dysplasia

Interventions

3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

to determine whether tissue in nepoplastic or non-neoplastic

Time frame: 1 day

Data from ClinicalTrials.gov

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