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

Anandasabapathy, Sharmila, M.D.

Status and phase: Terminated; Early Phase 1

Conditions: Colonic Dysplasia; Colon Polyps; Anal Dysplasia

Treatments: Drug: Proflavine Hemisulfate

Study type: Interventional

Identifiers

NCT01384240

GCO# 09-1040

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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183 participants in 1 patient group

Proflavine Hemisulfate

Experimental group

Treatment:

Drug: Proflavine Hemisulfate