Status:
TERMINATED
WavSTAT® Optical Biopsy System to Target Esophageal Biopsies
Lead Sponsor:
SpectraScience
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this study is to demonstrate the clinical utility of the WavSTAT Optical Biopsy System as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or c...
Detailed Description
In the clinical portion of this prospective study, the algorithm developed in the preclinical evaluation will be blindly tested using the pathologists' assessment of the biopsies as a gold standard to...
Eligibility Criteria
Inclusion
- The patient is between 18 and 80 years of age.
- The patient is willing to sign an informed consent form.
- The patient is a candidate for endoscopic examination
- Female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test.
Exclusion
- The patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy.
- The patient is pregnant or nursing by admission.
- The patient has other contraindications for physical biopsy.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00747136
Start Date
August 1 2008
End Date
March 1 2013
Last Update
April 14 2016
Active Locations (1)
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1
Department of Veterans Affairs
Kansas City, Missouri, United States, 64128