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

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

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.

Inclusion Criteria:

• Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
• Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment).
• Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT).
• Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones.
• Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones.
• At least 21 years of age.
• Able and willing to give informed consent.

Additional inclusion criteria for subgroup:

• Single ablation, using a single ablation needle, per tumor.

Exclusion Criteria:

• Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.).
• Planned ablation includes the use of more than two ablation needles, per tumor
• Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure.
• Pregnant or breastfeeding.
• Patient judged unsuitable for study participation by the physician for any other reason.
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
• Unable or unwilling to give informed consent.

Additional exclusion criteria for subgroup:

• Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
• Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.