Sponsor decision

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.