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

This study has been completed.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384227
First received: June 21, 2011
Last updated: January 8, 2016
Last verified: January 2016
  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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: 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 
Study First Received: June 21, 2011
Last Updated: January 8, 2016
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
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 29, 2016