CHAMPAIGN, ILLINOIS — Medical device company PhotoniCare Inc., today announced the successful initiation of a multi-site registered clinical study to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope.
According to the announcement, Children’s National Health System (Washington, D.C.) is the first initiated of two clinical sites involved in this registered multi-site clinical study, along with Carle Foundation Hospital (Urbana, Illinois).
The study is led by Dr. Diego Preciado, Children’s National, and Dr. Ryan Porter, Carle Hospital, along with a team of recognized otitis media experts at both clinical sites. This multi-center study plans to enroll a total of 300 pediatric subjects (up to 17 years old) undergoing tympanostomy tube surgery for chronic otitis media.
New Imaging Technology for Visualizing the Middle Ear
Unlike current diagnostic tools providing a view of the surface of the eardrum, PhotoniCare’s TOMi Scope uses an advanced light-based technology to see through the eardrum. For the first time, physicians can view a high-resolution depth image on-screen to directly visualize the middle ear contents.
Traditional methods can leave physicians in a position to make a diagnosis with very limited information, or employ invasive surgical procedures to diagnose middle ear pathologies. According to the company, PhotoniCare’s noninvasive solution eliminates the guesswork, providing users with objective data upon which to base their decisions.
“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. 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.”
–Ryan Nolan, PhotoniCare’s co-founder and VP of clinical operations
In 2015, PhotoniCare won an award from the FDA-funded National Capital Consortium for Pediatric Device Innovation (NCC-PDI), a collaboration of Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and University of Maryland’s A. James Clark School of Engineering.
“We are excited to work with PhotoniCare to study the accuracy and validity of Optical Coherence Tomography (OCT) imaging in the diagnosis of middle ear diseases,” said Dr. Preciado, vice chief of pediatric otolaryngology at Children’s National.
“If successful, this technology could dramatically alter the way children with ear problems are evaluated, enhancing our diagnostic power and ability to inform optimal treatments.”
“At Carle, putting patients’ needs first more and more often involves new technology to help our teams provide world-class care,” said Dr. Ryan Porter, otolaryngologist, surgeon and associate medical director for Carle Outpatient Surgery Centers. “Carle has been involved with the development of the OCT otoscope from its beginnings at the University of Illinois, and this has been a wonderful example of translational research taking an idea from the laboratory to a dramatic improvement in patient care. It’s exciting to work with PhotoniCare to expand our clinical abilities in innovative ways to serve our patients and their families.”
The registered clinical study in this publication is supported by the National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH) and from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) under Award Number R44DC014599.
More information about the study is available on ClinicalTrials.gov using identifier NCT03890107. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
PhotoniCare is a medical device company developing a handheld, low-cost imaging platform for the front lines of medicine. The TOMi Scope, the first product on the platform, provides physicians with a clear view of middle ear infections, one of the most common diseases in the world. For more information about PhotoniCare, visit the company’s website here.