NOLA (NeuWave Observational Liver Ablation) Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

Conditions
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Cancer of the Liver, Liver Cancer, Neoplasms, Liver

Intervention / Treatment
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* Device: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population<br>Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation. | Device: Microwave Ablation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | 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. | Day of ablation (Day 0) | 
| Technical efficacy | 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). | 7 days to 3 months post-ablation | 
| Target lesion recurrence (local recurrence) rate | 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. | 5 years post-ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy rate | 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. | 5 years post-ablation | 
| Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s)) | 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. | 5 years post-ablation | 
| Recurrence-free survival | 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. | 5 years post-ablation | 
| Overall survival | Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up. | 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 | 
| 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 number of probes used |  | 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 | 
| Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs) | 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. | 5 years post-ablation | 
| Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18) | 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. | 9-12 months post-ablation | 
| Numeric Pain Rating Scale | 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). | 7 days to 3 months post-ablation |