Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events. Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events. BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment. Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Study Type
OBSERVATIONAL
Enrollment
65
The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.
Mayo Clinic
Phoenix, Arizona, United States
Stanford Medicine
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Houston Methodist Hospital
Houston, Texas, United States
Safety - Adverse Events
Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.
Time frame: 1 year
Effectiveness - DICE
Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).
Time frame: 1 year
Sensitivity
Sensitivity of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.
Time frame: 1 year
Precision
Precision of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.
Time frame: 1 year
Questionnaire - Effect of BioTraceIO
The proportion of subjects in whom the treating physician indicates that, if the BioTraceIO Lite results had been available for use in patient management, it would have impacted their follow-up plan for patient management, compared to the CECT alone.
Time frame: 1 year
Difference between T=0 and T=24hrs CECT tissue damage
Difference in percentage between tissue damage volume as visualized at T=0 contrast-enhanced computed tomography (CECT) versus tissue damage volume as visualized at T=24hrs CECT.
Time frame: 1 year
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