NCT01384240

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

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Anandasabapathy, Sharmila, M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Polyps
• Colonic Dysplasia
• Anal Dysplasia

Interventions

Type	Name	Description
DRUG	Proflavine Hemisulfate	3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-07-01
• Completion: 2014-05-01
• First posted: 2011-06-29
• Last updated: 2016-01-12

Locations

1 site across 1 country: United States