NinePoint Medical commences clinical trial of OCT system
Falling on the heels of garnering FDA clearance for its Nvision VLE optical coherence tomography (OCT) system, NinePoint Medical (Cambridge, MA) has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett's esophagus using the system.
The single-arm, open-label observational trial will evaluate system performance in visualizing subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett’s esophagus, a common precursor to esophageal cancer. The trial is expected to enroll approximately 100 patients at five centers worldwide, including the Mayo Clinic (Jacksonville, FL, and Rochester, MN), Kansas University Medical Center (Kansas City, MO), Academic Medical Center (Amsterdam, The Netherlands), University College London in England, and University Hospital (Nantes, France).
The system provides two-dimensional, cross-sectional, real-time depth visualization of organs and tissues, and is the first volumetric OCT device cleared by the FDA for endoscopic imaging. The system uses a circumferential scanning technique and an automatic pullback to generate cross-sectional and longitudinal images simultaneously in real time.
The company remains on track to launch the system commercially in 2013. For more information on the clinical trials, please visit www.clinicaltrials.gov.