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

This study has been terminated.
(Study is closed as the PI transferred to another institution.)
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D. Identifier:
First received: June 27, 2011
Last updated: January 8, 2016
Last verified: January 2016
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 Intervention Phase
Colon Polyps Colonic Dysplasia Anal Dysplasia Drug: Proflavine Hemisulfate Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Anandasabapathy, Sharmila, M.D.:

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

Enrollment: 183
Study Start Date: April 2010
Study Completion Date: May 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: June 27, 2011
Last Updated: January 8, 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 processed this record on September 21, 2017