Ninepoint Medical, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

ABSTRACT Bile duct strictures can lead to painful clinical symptoms and can be caused by a wide range of conditions from benign diseases to cholangiocarcinomaa deadly cancer of the bile duct withyear survival rates as low asfor late stage diseaseThe management and prognosis of bile duct strictures varies significantlyso accurate diagnosis and differentiation between malignant and benign strictures is criticalCurrently the most common way to differentiate a biliary stricture is to perform biopsy or brush cytology with the use of endoscopic retrograde cholangiopancreatographyERCPHoweverthe diagnostic yield is low due to small tissue sampled with limited image guidanceEndoscopic optical coherence tomographyOCTprovides wide field imaging of the surface and subsurface tissue microstructureand has been previously evaluated for use in the biliary system with promising resultsThe goal of this project is to develop and evaluate a single device to perform precise image guided biopsy within the biliary systemHerewe will combine OCT to visualize abnormalities over a wide field of view to provide high disease sensitivityalong with an integrated tissue acquisition tool for pathological confirmation of abnormalities to provide high specificityIn aimwe will develop a prototype miniaturized and flexible OCT probe with integrated tissue acquisitionenabling precise image guided biopsyAimis to evaluate the feasibility of this tool in a simulated biliary model to acquire tissue samples under image guidance and verify the one to one co registration PROJECT NARRATIVE The goal of this project is to develop a flexible optical coherence tomography device to perform precise image guided biopsy within the biliary systemAccurate diagnosis of indeterminate biliary strictures is a major challenge resulting in overmisdiagnosisWe aim to improve diagnosisleading to better treatment and reduced healthcare costs