Clinical study to evaluate OCT imaging device for chronic middle ear infection

May 2, 2019

The TOMi Scope uses OCT imaging to see through the eardrum, allowing direct visualization of the middle ear contents.

Medical device company PhotoniCare (Champaign, IL) has initiated a multisite registered clinical study to evaluate the optical coherence tomography (OCT) imaging capabilities and image analysis performance of the company's TOMi Scope.

Children's National Health System (Washington, DC) is the first initiated of two clinical sites involved in the study, along with Carle Foundation Hospital (Urbana, IL). 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 multicenter study plans to enroll a total of 300 pediatric subjects (up to 17 years old) undergoing tympanostomy tube surgery for chronic otitis media.

Current diagnostic tools can only provide a view of the surface of the eardrum, while the disease resides in the middle ear, behind the eardrum. Physicians are left to make a diagnosis with very limited information, or employ invasive surgical procedures to diagnose middle ear pathologies. Recognizing this limitation, TOMi Scope uses OCT imaging to see through the eardrum, allowing physicians to view a high-resolution depth image onscreen to directly visualize the middle ear contents.

In 2015, the company won an award from the U.S. 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.

"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," Preciado says.

For more information, please visit photoni.care.