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

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.
• •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.