PhotoniCare, a Champaign-based medical device company, announced that a multi-site registered clinical study has been initiated to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope.
PhotoniCare said that the Children’s National Health System in Washington has initiated the first of two clinical sites involved in the registered multi-site clinical study, while Carle Foundation Hospital in Urbana hosted the second.
Dr. Diego Preciado from Children’s National and Dr. Ryan Porter from Carle Hospital are leading the clinical study, along with a team of recognized otitis media experts at both clinical sites.
PhotoniCare said that the multi-center study intends to enroll a total of 300 pediatric subjects, under 17 years of age, who are undergoing tympanostomy tube surgery for chronic otitis media.
Using PhotoniCare’s TOMi Scope, physicians can take advantage of an advanced light-based technology to see through the eardrum. The device displays a high-resolution depth image on the screen to directly visualize the middle ear contents.
PhotoniCare co-founder and VP clinical operations Ryan Nolan said: “We are truly grateful for the opportunity to continue our strong collaborative history with Children’s National and Carle hospitals.
“We’re excited to start this pivotal study and anticipate that this work will continue to expand the body of evidence showing the TOMi Scope’s ability to noninvasively provide advanced diagnostic information, empowering physicians to more accurately assess, diagnose and treat middle ear infections.”
The company claimed that all the other diagnostic tools can only provide a view of the surface of the eardrum, while the disease exists in the middle ear, behind the eardrum, which results physicians making diagnosis with very limited information, or employ invasive surgical procedures to diagnose middle ear pathologies.
Furthermore, PhotoniCare’s noninvasive solution would eliminate the presumption, providing users with objective data upon which to base their decisions.
Nolan said: “As a parent and patient myself, my personal passion at PhotoniCare is to improve the care provided to patients suffering from this all too common disease.”
PhotoniCare received an award from National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is an FDA-funded collaboration of Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland’s A. James Clark School of Engineering, in 2015.