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Clinical Trials/NCT01384240
NCT01384240
Terminated
Early Phase 1

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

Anandasabapathy, Sharmila, M.D.1 site in 1 country183 target enrollmentApril 2010

Overview

Phase
Early Phase 1
Intervention
Proflavine Hemisulfate
Conditions
Colon Polyps
Sponsor
Anandasabapathy, Sharmila, M.D.
Enrollment
183
Locations
1
Primary Endpoint
to determine whether tissue in nepoplastic or non-neoplastic
Status
Terminated
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Anandasabapathy, Sharmila, M.D.
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Proflavine Hemisulfate

Intervention: Proflavine Hemisulfate

Outcomes

Primary Outcomes

to determine whether tissue in nepoplastic or non-neoplastic

Time Frame: 1 day

Study Sites (1)

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