Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384227
First received: June 21, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.


Condition Intervention Phase
Barrett's Esophagus
Drug: Proflavine Hemisulfate
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

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: 40
Study Start Date: February 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Proflavine Hemisulfate
    Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
  Eligibility

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

Inclusion Criteria:

  • Barrett's without dysplasia
  • Barrett's with dysplasia
  • Esophageal Adenocarcinoma

Exclusion Criteria:

  • Subjects unfit for standard upper endoscopy
  • Subjects currently receiving chemo or radiation treatment
  • Subject currently receiving PDT or ablation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01384227

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

No publications provided

Responsible Party: Sharmila Anandasabapathy, MD, Associate Professor of Medicne, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier: NCT01384227     History of Changes
Obsolete Identifiers: NCT00755625
Other Study ID Numbers: GCO # 08-1190
Study First Received: June 21, 2011
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Anandasabapathy, Sharmila, M.D.:
Barrett's esophagus
in vivo imaging
image guide microscope

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 July 22, 2014