Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
Megadott ok: Sponsor decision
Key facts
- Where
- Philadelphia, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Einstein Medical CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Techsomed Medical Technologies LTD
- Trial code
- NCT05582018
- Record updated
- 2025. szeptember 15.
- Original description
Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation proceduresRead full original descriptionShow less
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: 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: Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period; 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; 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.