A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,254
- 试验地点
- 41
- 主要终点
- Target lesion recurrence (local recurrence) rate
研究概览
简要总结
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
详细描述
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions.
This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up.
Enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU).
- •Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database.
- •Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC).
排除标准
- •Patients with a life expectancy of less than 1 year, in the opinion of the treating physician.
- •Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation.
- •Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver. Note: roll-over patients from previous NeuWave trials are permitted.
研究组 & 干预措施
Population
Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
干预措施: Microwave Ablation (Device)
结局指标
主要结局
Target lesion recurrence (local recurrence) rate
时间窗: 5 years post-ablation
Target lesion recurrence (local recurrence) rate is evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.
Technical success
时间窗: Day of ablation (Day 0)
Technical success, defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e. the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
Technical efficacy
时间窗: 7 days to 3 months post-ablation
Technique efficacy, ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e., the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, at Visit 3 (between 7 days and less than 3 months post-ablation).
Number of Patients Whose Ablation Resulted in Technical Success
时间窗: Immediately post-ablation (Day 0)
Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
Number of Patients Whose Ablation Resulted in Technique Efficacy
时间窗: Between 7 days and less than 3 months post-ablation
Technique efficacy is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray at Visit 3 (between 7 days and less than 3 months post-ablation).
Target Lesion Recurrence Rate
时间窗: Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation.
Target lesion recurrence (local recurrence) was evaluated at every visit after ablation of the target lesion(s) and assessed by CT, MRI, PET, US, and/or X-ray.
次要结局
- Secondary efficacy rate(5 years post-ablation)
- Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s))(5 years post-ablation)
- Economic impact of ablation as evaluated by complete procedure duration(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs)(5 years post-ablation)
- Recurrence-free survival(5 years post-ablation)
- Overall survival(5 years post-ablation)
- Economic impact of ablation as evaluated by number of probes used(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Economic impact of ablation as evaluated by complete ablation duration(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Economic impact of ablation as evaluated by number of ablations(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Economic impact of ablation as evaluated by length of hospital stay(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Economic impact of ablation as evaluated by types of probes used(Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
- Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18)(9-12 months post-ablation)
- Numeric Pain Rating Scale(7 days to 3 months post-ablation)
- Overall Survival(Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation.)