Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation. Sample size - 30 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
Use of the device for planning, monitoring and assessment of liver tissue ablations
Einstein Medical Center
Philadelphia, Pennsylvania, United States
Effectiveness
The percentage of patients for whom (1) probe(s) position suggestion provided by the BioTraceIO 360 device is in agreement with the planned probe(s) position, as determined by the physician without the use of the device, or (2) clinically feasible probe(s) positioning suggestion was provided by the BioTraceIO 360 device, in addition to the planned probe(s) position by the physician without the use of the device.
Time frame: 1 year
Safety
Incidence and severity of device-related adverse
Time frame: 1 year
Planning Module
The proportion of subjects in whom the physician has made changes and/or reported increased confidence to the planned ablation procedure after using the BioTraceIO 360 Planning Module compared to without using it.
Time frame: 1 year
Monitoring Module
A non-validated qualitative assessment for the physician regarding confidence during the procedure without and with the use of BioTraceIO 360 Monitoring Module if they could have made clinical decisions based on the use of the device.
Time frame: 1 year
Assessment Module (1)
A non-validated qualitative assessment on whether there were subjects, in whom the physician indicated that they would have changed the procedure and/or follow-up decision if they could have made clinical decisions based on the visualization of the tumor compared to the necrosis, using the BioTraceIO 360 Assessment Module at the end of the procedure.
Time frame: 1 year
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