Clear Guide Medical, Inc. SBIR Phase I Award, April 2018

Clear Guide MedicalIncSummary In an earlier Phase II SBIRTopic NumberSBIRHHSNCRFPNCClear Guide Medical developed the Clear Guide SCENERGYa compact guidance system for CTultrasound fusion and easy instrument guidanceBuilding on this fundamental technologyClear Guide Medical proposes to make the SCENERGY CT onlywithout the use of real time ultrasoundFeedback from potential customers in interventional radiology has indicated that many physicians prefer to use only CT guidance without adding ultrasound to the procedurewhich is a change to their existing workflowThis present application outlines the steps to adapt the existing FDA cleared SCENERGY to that marketThis application describes the technological research plan to address key technical product developments and to obtain some of the nonclinical but necessary data to support regulatory filings for a CT only SCENERGY in the futurePublic health implications of this proposal include significantly lowered radiation for CT guided interventional proceduresa benefit to patients and physicians alikeAdditionallythere may be time savings per procedure by reducing the number of CTs takenas well as cost savings from greater throughput per CT machine Project Narrative It has been shown that using a guidance system can help reduce the amount of ionizing radiation involved in CT guided interventionswhich are responsible for the increasing incidences of head and neck cancers among interventional radiologistsWe aim to develop a small footprintself contained tablet based navigation system that can be used for planningregistrationand guidance of such proceduresThe system will require little training and will add minimal overhead to the current workflow of the operating room while helping reduce the number of CT images required for instrument guidance and significantly reducing the intervention times