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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
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 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
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Fluorescein
Proflavine
Anti-Infective Agents
Anti-Infective Agents, Local
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014