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Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

This study has been completed.
Sponsor:
Collaborator:
William Marsh Rice University
Information provided by (Responsible Party):
Anandasabapathy, Sharmila, M.D.
ClinicalTrials.gov Identifier:
NCT01384864
First received: June 28, 2011
Last updated: January 7, 2016
Last verified: January 2016

June 28, 2011
January 7, 2016
August 2011
December 2015   (final data collection date for primary outcome measure)
to determine whether tissue is neoplastic or non-neoplastic [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01384864 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia
The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.
Not Provided
Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Barrett's Esophagus
  • Intraepithelial Neoplasia
Drug: proflavine
2-6 ml of 0.01% proflavine
Other Name: Proflavine hemisulfate
Experimental: treatment
fluorescent imaging with proflavine
Intervention: Drug: proflavine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer)

Exclusion Criteria:

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01384864
GCO# 09-0696 Project 3
Yes
Not Provided
Not Provided
Anandasabapathy, Sharmila, M.D.
Anandasabapathy, Sharmila, M.D.
William Marsh Rice University
Not Provided
Anandasabapathy, Sharmila, M.D.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP