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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384240
Recruitment Status : Terminated (Study is closed as the PI transferred to another institution.)
First Posted : June 29, 2011
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.

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.

Condition or disease Intervention/treatment Phase
Colon Polyps Colonic Dysplasia Anal Dysplasia Drug: Proflavine Hemisulfate Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
Study Start Date : April 2010
Primary Completion Date : July 2013
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Proflavine Hemisulfate Drug: Proflavine Hemisulfate
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
Other Name: Proflavine

Primary Outcome Measures :
  1. to determine whether tissue in nepoplastic or non-neoplastic [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384240

United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
Principal Investigator: Sharmila Anandasabapathy, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anandasabapathy, Sharmila, M.D. Identifier: NCT01384240     History of Changes
Other Study ID Numbers: GCO# 09-1040
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Anandasabapathy, Sharmila, M.D.:
colon polyps
colonic dysplasia
anal dysplasia

Additional relevant MeSH terms:
Colonic Polyps
Pathologic Processes
Intestinal Polyps
Pathological Conditions, Anatomical
Anti-Infective Agents, Local
Anti-Infective Agents