NinePoint Medical, a developer of medical devices for in vivo pathology, has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using its proprietary Nvision VLE Imaging System, which received 510(k) clearance from the FDA earlier this year.
The single-arm, open-label observational trial is designed to evaluate the performance of the Nvision VLE Imaging System to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett’s esophagus, one of the most common precursors to esophageal cancer. The trial is expected to enroll approximately 100 patients at five leading centers: the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn.; Kansas University Medical Center in Kansas City, Mont.; Academic Medical Center in Amsterdam; University College London; and University Hospital in Nantes, France.
The Nvision VLE Imaging System is an imaging tool used for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. It is also the first volumetric optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging that uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real time.
“The Nvision VLE Imaging System has the potential to improve and accelerate the diagnosis and treatment of patients with potentially diseased tissues, including gastrointestinal conditions like Barrett’s esophagus, by providing physicians with high-resolution, volumetric images in real time,” said Charles Carignan, M.D., president and CEO of NinePoint Medical.
Ninepoint plans to commercially launch Nvision VLE Imaging System in 2013, said Carignan.