Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer
NCT01384708 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2016-01-11
Summary
The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides \> 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.
Conditions
- Squamous Cell Cancer
Interventions
- DRUG
-
proflavine
1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
Sponsors & Collaborators
-
William Marsh Rice University
collaborator OTHER -
Anandasabapathy, Sharmila, M.D.
lead INDIV
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2013-10-31
- Completion
- 2013-10-31
Countries
- United States
Study Locations
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