Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 5
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
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).
详细描述
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) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.
BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
- •Subject cannot tolerate/undergo contrast-enhanced CT.
- •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.
- •Pregnant or lactating
- •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.
结局指标
主要结局
Safety - Adverse Events
时间窗: 1 year
Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.
Effectiveness - DICE
时间窗: 1 year
Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).
次要结局
- Precision(1 year)
- Difference between T=0 and T=24hrs CECT tissue damage(1 year)
- Sensitivity(1 year)
- Questionnaire - Effect of BioTraceIO(1 year)