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

This study has been terminated.
(Study was stopped because of low/no enrollement. No subjects were enrolled over the past year.)
Sponsor:
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384695
First received: June 28, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
GERD
Barrett's Esophagus
Drug: Fluorescein
Drug: Proflavine hemisulfate
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia - Project 1

Resource links provided by NLM:


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

Primary Outcome Measures:
  • to determine whether tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treament arm
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)
Experimental: treatment arm
confocal imaging using contrast agent proflavine
Drug: Fluorescein
fluorescent contrast agent, Fluorescein 5ml

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384695

Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
  More Information

No publications provided

Responsible Party: Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01384695     History of Changes
Other Study ID Numbers: GCO# 09-0696 Project 1
Study First Received: June 28, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anandasabapathy, Sharmila, M.D.:
Barrett's esophagus
confocal microendoscopy

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014