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

Launched by TECHSOMED MEDICAL TECHNOLOGIES LTD · Nov 29, 2022

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Gender

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Eligibility criteria

• 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.