A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

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: NCT01384695
Recruitment Status : Terminated (Low/no enrollment. No subjects were enrolled over the past year.)
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 gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.

Condition or disease Intervention/treatment Phase
GERD Barrett's Esophagus Drug: Fluorescein Drug: Proflavine hemisulfate Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluorescein
Confocal imaging using contrast agent fluorescein
Drug: Proflavine hemisulfate
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
Other Name: Proflavine
Experimental: Proflavine hemisulfate
confocal imaging using contrast agent proflavine
Drug: Fluorescein
fluorescent contrast agent, Fluorescein 5ml

Primary Outcome Measures :
  1. to determine whether tissue is neoplastic 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:

  • patient 18 years or older
  • colonoscopy for screening or surveillance of polyps or disease of colon
  • anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

  • patient unable to provide informed consent
  • patient found unfit for standard colonoscopy or anoscopy with biopsies

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): NCT01384695

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, M.D. Mt. Sinai School of Medicine

Responsible Party: Anandasabapathy, Sharmila, M.D. Identifier: NCT01384695     History of Changes
Other Study ID Numbers: GCO# 09-0696 Project 1
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.:
Barrett's esophagus
confocal microendoscopy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Anti-Infective Agents, Local
Anti-Infective Agents