NinePoint Medical, involved in devising medical instruments for in vivo pathology, has begun clinical trials to assess superior resolution optical imaging of the Barrett’s esophagus using its own Nvision VLE Imaging System.
Early this year, Food and Drug Administration (FDA) issued 510(k) clearance for the imaging system. The imaging system is one of the first volumetric optical coherence tomography (OCT) device to obtain FDA certification.
The evaluation of the Nvision system’s performance is carried out on patients on whom esophagogastroduoenoscopy (EGD) for confirmed or suspected Barrett’s esophagus is being conducted, specifically, for observing the subsurface tissues in the patients. Around 100 patients will be participating in the clinical trial from five medical centres, namely, University Hospital in Nantes of France, University College from London, Academic medical Centre located in Amsterdam, Kansas University Medical Center in Kansas, Missouri and Mayo Clinic in Jacksonville, Fla. and Rochester.
The imaging system can be used to evaluate the microstructure of human tissues. It offers cross sectional, two dimensional images and has real time depth visualization. This allows the pathologists and clinicians to observe more real time tissue and organ images of about 3mm depth with<10µ resolution. This OCT device will produce longitudinal and cross sectional real time images at the same time using automated pullback and circumferential scanning techniques.
The CEO and President of the company, Charles Carignan , M.D., stated that the imaging system has the capability to enhance the diagnostic approaches and curability of patients with gastrointestinal diseases and added that the company has developed this technology in a fast manner and the clinical trial has begun as per schedule.
NinePoint Medical focuses on devices that are used for the detection of diseases in tissues including mucosa. The company aims to provide better solutions for diagnosis and hence, patients shall be cured faster.