A Prospective Evaluation of the WavSTAT® Optical Biopsy System to Target Esophageal Biopsies: An Adjunctive Tool to Assist the Endoscopist to Identify Dysplasia or Cancer
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 determine the clinical sensitivity and specificity of the
WavSTAT Optical Biopsy System to identify dysplastic or cancerous tissue in the esophagus.
In addition, the endoscopist's unaided clinical sensitivity and specificity to identify
dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual
assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia
or cancer prior to performing the biopsy The endoscopist's assessment will be correlated and
compared with the pathologist's interpretation. The clinical utility of the WavSTAT System
to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the
esophagus will be evaluated by testing the hypothesis that the sensitivity of a
WavSTAT-assisted endoscopic examination improves that of standard endoscopy alone.
Observational Model: Case-Only, Time Perspective: Prospective
Determine sensitivity/specificity to identify dysplasia/cancer in the esophagus WavSTAT System alone, endoscopist alone/combination of WavSTAT and endoscopist. Sensitivity of the endoscopist will be compared to combination of endoscopist and WavSTAT.
9-15 months estimated
United States: Institutional Review Board
|Department of Veterans Affairs||Kansas City, Missouri 64128|