In an earlier Phase II SBIR (Topic Number: SBIR 306; HHSN261201300062C; RFP: N44C031014-51), Clear Guide Medical developed the Clear Guide SCENERGY, a compact guidance system for CT- ultrasound fusion and easy instrument guidance. Building on this fundamental technology, Clear Guide Medical proposes to make the SCENERGY CT-only, without the use of real-time ultrasound. Feedback from potential customers in interventional radiology has indicated that many physicians prefer to use only CT-guidance without adding ultrasound to the procedure, which is a change to their existing workflow. This present application outlines the steps to adapt the existing FDA-cleared SCENERGY to that market. This 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 future. Public health implications of this proposal include significantly lowered radiation for CT-guided interventional procedures, a benefit to patients and physicians alike. Additionally, there may be time savings per procedure by reducing the number of CTs taken, as well as cost savings from greater throughput per CT machine.
It has been shown that using a guidance system can help reduce the amount of ionizing radiation involved in CT-guided interventions, which are responsible for the increasing incidences of head and neck cancers among interventional radiologists. We aim to develop a small-footprint, self-contained tablet-based navigation system that can be used for planning, registration, and guidance of such procedures. The 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.
