NinePoint Medical has started a clinical trial of its Nvision VLE imaging system, designed to evaluate high-resolution optical imaging of Barrett's esophagus, a condition that leads to esophageal cancer.
The FDA-cleared Nvision imaging system is a next-generation optical coherence tomography (OCT) device that uses a circumferential scanning technique and an automatic pullback to produce cross-sectional and longitudinal images simultaneously in real time.
The single-arm open-label observational trial is intended to investigate the performance of the Nvision VLE imaging system to visualise subsurface tissue in patients undergoing esophagogastroduodenoscopy (EGD) for suspected or confirmed Barrett's esophagus.
The company's imaging system will allow physicians and pathologists to view real-time, high-resolution, volumetric images of organs and tissues up to 3mm deep at less than ten micron resolution.
NinePoint Medical president and CEO Charles Carignan said the 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.
"We have made rapid and significant progress in advancing the development of this technology, including 510(k) clearance from the FDA for a general indication and the initiation of this clinical trial for use in patients with Barrett's esophagus as planned," Carignan added.
The commercial launch of the imaging system is expected in 2013.