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1. Technical success (Time Frame - 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.
2. Technical efficacy (Time Frame - 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).
3. Target lesion recurrence (local recurrence) rate (Time Frame - 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.
Secondary outcome:
1. Secondary efficacy rate (Time Frame - 5 years post-ablation): Secondary efficacy rate, defined as the percentage of soft tissue lesions that have undergone successful repeat ablations (target or non-target) following identification of local soft tissue lesion progression, as assessed by CT, MRI, PET, US, and/or X-ray. A successful repeat ablation will be defined as ablation of the lesion 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 lesion plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
2. Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s)) (Time Frame - 5 years post-ablation): Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s)), 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.
3. Recurrence-free survival (Time Frame - 5 years post-ablation): Recurrence-free survival, 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.
4. Overall survival (Time Frame - 5 years post-ablation): Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up.
5. Economic impact of ablation as evaluated by complete procedure duration (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
6. Economic impact of ablation as evaluated by complete ablation duration (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
7. Economic impact of ablation as evaluated by number of ablations (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
8. Economic impact of ablation as evaluated by length of hospital stay (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
9. Economic impact of ablation as evaluated by number of probes used (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
10. Economic impact of ablation as evaluated by types of probes used (Time Frame - Day of ablation (Day 0) through hospital discharge, estimated up to 1 week)
11. Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs) (Time Frame - 5 years post-ablation): Incidence of adverse events (AEs) (SAEs) that are deemed at least unlikely related to the procedure or device and all serious adverse events (SAEs) from day of ablation through the end of the study.
12. Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18) (Time Frame - 9-12 months post-ablation): European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and liver-specific QLQ-HCC18 are questionnaires that will be completed at the Ablation Visit (pre-ablation), and each study visit afterwards, up to 9-12 months post-ablation.
Note: These two questionnaires were chosen as tools to assess overall health status/quality of life in the patient population with soft-tissue liver lesions.
13. Numeric Pain Rating Scale (Time Frame - 7 days to 3 months post-ablation): The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at the Ablation Visit (pre- and post-ablation), and at the first study visit after the ablation (7 days to 3 months post-ablation).
Microwave Ablation: Patients who meet the eligibility criteria will undergo microwave ablation (MWA) with the NEUWAVE Microwave Ablation System with or without Ablation Confirmation of at least one soft-tissue liver lesion, in accordance with the study site's standard-of-care (SOC) practices.
Quelle: ClinicalTrials.gov
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