EndoVigilant starts Pivotal Clinical Study to demonstrate Artificial Intelligence enabled assistance to gastroenterologists for detection of polyps during Colonoscopy

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An important milestone on the way to receiving FDA market clearance.

Dr. Shai Friedland, Professor of Medicine at Stanford University, the Principal Investigator for the study commented "EndoVigilant’s CADe application has the potential to decrease adenomas miss rates in colonoscopy and therefore, reduce the occurrence of interval colon cancers."

EndoVigilant, Inc., a privately held company developing an artificial intelligence (AI) enabled medical imaging platform for endoscopy procedures announced that the pivotal clinical study for its first application using the platform is now in progress at multiple sites across the US. The first application focuses on real-time computer aided detection (CADe) assistance for improving polyp detection during colonoscopies.

Colonoscopy is a gold standard screening test for screening of colon cancer, which continues to be one of the leading causes of cancer related deaths in the US. Even though approximately 18 million colonoscopy procedures are performed annually in the US, adenomatous polyp miss rate as high as 26% often results in missed cancers.

EndoVigilant’s first application has been developed to assist gastroenterologists in real-time with polyp detection with the goal of reducing adenomatous polyp miss rate and hence, the occurrence of interval colon cancers. EndoVigilant’s software has been developed using state of the art deep learning AI algorithms and is trained on images and videos collected from practicing gastroenterologists from multiple academic and private endoscopy centers across the US. It is interoperable with existing endoscopy systems and can be deployed in a plug-and-play manner without requiring changes or costly upgrades to those systems.

Earlier this year, EndoVigilant reached an agreement with the FDA on the design of its pivotal clinical study. The study is a prospective, multi-center, randomized controlled trial with sites and investigators from both academic and community settings. The study is currently being performed to support the company’s planned filing to the FDA to obtain market clearance in the US.

Dr. Shai Friedland, Professor of Medicine at Stanford University, the Principal Investigator for the study commented “AI is a rapidly growing field with multiple medical applications in gastrointestinal endoscopy. EndoVigilant’s CADe application for colonoscopy procedures has the potential to improve polyp detection rates, decrease adenomas miss rates in colonoscopy and therefore, reduce the occurrence of interval colon cancers.”

“The progress of clinical pivotal study highlights our commitment to demonstrate the clinical benefits of EndoVigilant’s CADe application and getting it in the hands of gastroenterologists as soon as possible,” stated Vineet Sachdev, CEO and Co-Founder of EndoVigilant. “Based on strong results from pilot studies earlier, we are confident that this pivotal study will show increased adenomatous polyp detection without introducing significant risk when our software is used by gastroenterologists while performing colonoscopy procedures. We expect the pivotal clinical study to complete in Q1 2021.”

About EndoVigilant

Headquartered in Maryland, home to one of the largest life sciences clusters in the US, EndoVigilant, Inc., is a privately-held company developing an AI enabled medical imaging platform for endoscopy procedures. The platform’s first application is focused on improving colon polyp detection during colonoscopies with additional applications planned for the entire digestive tract. For more information, please visit http://www.endovigilant.com .

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