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

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ClinicalTrials.gov Identifier: NCT01384227
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Barrett's Esophagus Drug: Proflavine Hemisulfate Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Study Start Date : February 2009
Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Proflavine Hemisulfate Drug: Proflavine Hemisulfate
Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
Other Name: Proflavine


Outcome Measures

Primary Outcome Measures :
  1. To determine whether tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ]

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01384227


Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Anandasabapathy, Sharmila, M.D.
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Sharmila Anandasabapathy Mt. Sinai School of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

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

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