Clear Guide Medical, Inc. SBIR Phase I Award, September 2019

Clear Guide MedicalIncSummary Wrong level spine surgery has been classified as anever eventmeaning an adverse event that is unambiguousclearly identifiable and measurableseriousresulting in death or significant disabilityand usually preventableHoweverunlike other medical errors such as wrong side or wrong site surgeries which have been significantly reduced through the use of checklists and other protocol changeswrong level spine surgery numbers remain stubbornly highGrimmSince FebruaryCMS has not paid for any costs associated with wrong site surgeries and many state and private insurers have followed suitWongMoreoverthe occurrence of wrong level spine surgeries often results in legal action with significant financial awards to patientsGoodkinmaking it a costly error for both the physician and hospitalAlthough wrong site surgery occurs in all surgical specialtiesthe majority of cases have been recorded in orthopedic surgeryAmbeUp toof spine surgeons report having performed wrong level surgeryModyand WattsconcludedWrong level surgery of the spine is a significant safety issue facing the field that continues to occur despite surgical teams following guidelinesAs poor radiograph quality and interpretability were the most common root causes of these eventsinterventions aimed at optimizing image quality and accurate interpretation would be a logical first actionThis proposal aims to solve the wrong level spine surgery problem by registering the patient s back directly to the preoperative CT or MRI where image quality is not an issuehaving the surgeon mark on the MRI or CT screen the entry point for surgeryand then projecting that point onto the patient s backan augmented reality innovation that can be seen by everyone in the ORFor the roughlyinpatients who endures a wrong level spine surgeryModyeliminating the risk of wrong level surgery can facilitate the decision to undergo spine surgery at alland eliminate potentially life changing complicationsThe public health implications of this proposal are fewer wrong level spine surgeries which will benefit not only patients but also presumably reduce lawsuits against physicians and hospitalsthereby reducing insurance claims and thereby policy costsHospitalstoocan reduce costs by avoiding costly repeat repair surgeries that are unreimbursed Project Narrative This NIH Phase I SBIR proposal will designprototype and test an augmented reality device to project onto a spine surgery patient the exact location of the surgery site based on CT or MRI imagesthereby avoiding wrong level spine surgerythe most common wrong site surgery