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Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations

Use of the device for planning, monitoring and assessment of liver tissue ablations

BioTraceIO 360

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

Single-center prospective single-arm clinical investigation.

Sample size - 10 subjects.

Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)

Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

A non-validated qualitative assessment on whether there were subjects, for whom the BioTraceIO 360 Assessment Module indicated an incomplete ablation of the target tissue, compared to follow up 1-month post-procedure imaging.

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

Incidence and severity of device-related adverse

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.

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.

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.

Techsomed Medical Technologies LTD

Inbal Amitai

Yossi Abu

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.

Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

A paired comparison between the DICE similarity coefficient, assessed for BioTraceIO 360 as measured during the ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure imaging (T=24), to the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure imaging (T=0) and the tissue damage area based on 24-hours post-procedure imaging (T=24).

Sensitivity of the BioTraceIO 360 at T=0 compared to imaging at T=24.

Precision of the BioTraceIO 360 at T=0 compared to imaging at T=24.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)	NCT05641922	Hepatocellular ... Metastatic Live...	BioTraceIO 360	21 Years -	Techsomed Medical Technologies LTD
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures	NCT05582018	Hepatocellular ... Metastatic Live...	BioTraceIO 360	21 Years -	Techsomed Medical Technologies LTD
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)	NCT05641922	Hepatocellular ... Metastatic Live...	BioTraceIO 360	21 Years -	Techsomed Medical Technologies LTD

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