Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue A… (NCT04970212) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
United States65 participantsStarted 2021-09-24
Plain-language summary
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.
Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.
✓. At least 21 years of age
✓. 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 (minimum of 1cm), based on the physician's discretion.
✓. Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
✓. Single ablation, using a single ablation needle, per tumor.
✓. Able and willing to give informed consent.
Exclusion criteria
✕. Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
✕. Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
✕. Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.