| Primary | Number of Participants Whose Ablation Resulted in Technical Success | Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question "Confirm outcome of ablation". | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Count of Participants | | Participants | | Post ablation procedure (Day 0) up to 4 days | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
| | | Title | Denominators | Categories |
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| PI Assessment | | | | Independent Reviewer Assessment | | |
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| Secondary | Number of Participants Whose Ablation Resulted in Primary Technique Efficacy | Number of participants whose ablation resulted in primary technique efficacy were reported. Primary technique efficacy was defined as a complete tumor ablation with adequate or insufficient ablation margin, based on contrast-enhanced MRI and CT scans follow-up at 1 month after the ablation procedure, evaluated by the independent reviewer and PI based on the response to the question "Confirm outcome of ablation". The primary technique efficacy was achieved if responses were either "Complete tumor ablation with adequate margin" or "Complete tumor ablation with insufficient margin". | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Count of Participants | | Participants | | At 1 month after the ablation procedure on Day 0 | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Percentage of Participants With Local Tumor Progression (LTP) | Percentage of participants with LTP were reported. The first LTP rate was defined as one minus primary efficacy rate. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of local tumor progression (LTP) based on the independent reviewer's assessment and PI assessment. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Number | | percentage of participants | | At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0 | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Percentage of Participants With Primary Efficacy | Percentage of participants with primary efficacy based on the independent reviewer and PI assessment were reported. Primary efficacy rate was defined as percentage of participants with target tumors successfully eradicated following the ablation procedure and measured at each follow-up visit post-ablation. Primary efficacy was achieved when any target tumor had been successfully ablated at the Visit 2 ablation (Technical success achieved) and had no evidence of LTP based on the independent reviewer's assessment and PI assessment. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Number | | percentage of participants | | At 1, 3, 6, 9, 12, 18, 24, 30 and 36 months post ablation on Day 0 | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Percentage of Participants With Secondary Efficacy | Percentage of participants with secondary efficacy based on the independent reviewer and PI assessment were reported. Secondary efficacy rate was defined as percentage of participants with target tumors that had undergone successful repeat ablation following identification of local tumor progression. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Data for this outcome measure was not collected and analyzed as no participant had undergone repeat ablations. | Posted | | | | | | From time of first ablation (Day 0) up to 36 months | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Progression Free Survival (PFS) Rate | PFS rate was defined as the percentage of participants with PFS. PFS was defined as the time from the first ablation until LTP (first LTP rate was defined as one minus primary efficacy rate), any identification of a new (nontarget) lesion/tumor during follow-up, or death due to any cause (whichever occurs first). PFS rate based on independent reviewer's assessment and PI assessment was reported. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. Here "N" (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies the number of participants analyzed for specified categories. | Posted | | Number | | Percentage of participants | | At 36 months after the ablation procedure on Day 0 | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Overall Survival (OS) Rate | OS rate was defined as the percentage of participants with OS. OS was defined as the time from the first ablation until death due to any cause. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Number | | percentage of participants | | At 36 months after the ablation procedure on Day 0 | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Percentage of Participants With Adverse Events (AEs) Within 3 Months Post Ablation | Percentage of participants with AEs within 3 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device. | Safety analysis set (SAF) included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not. | Posted | | Number | | percentage of participants | | From time of first ablation (Day 0) up to 3 months post ablation | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Percentage of Participants With Adverse Events Within 36 Months Post Ablation | Percentage of participants with AEs within 36 months post ablation were reported. An AE was an untoward medical occurrence (sign, symptom or disease) in a participant, and which did not necessarily have a causal relationship with the study medical device. | SAF included all participants in whom the microwave ablation procedure was attempted, that is, started and regardless of whether it got completed as planned or not. | Posted | | Number | | percentage of participants | | From time of first ablation (Day 0) up to 36 months post ablation | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Change From Baseline in Visual Analogue Scale (VAS) Pain Score | Change from baseline in VAS pain scores were reported. VAS pain score was a self-reported pain score on a 100 millimeter (mm) scale which ranged from ranged from 0 mm (no pain) to 100 mm (severe pain). Higher score indicated severe pain. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline (Pre-Ablation), Day 0 (post ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Scale Score | Change from baseline in EORTC QLQ-C30 scale score were reported. EORTC QLQ-C30 contains 30 questions for assessing overall health in cancer patients. The questions reflect how patients felt during the past week and are scored 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) except for the last two questions, which are scored on a 7-point Likert Scale from 1-7 (1=very poor to 7=excellent). All the questions were transformed to a 0-100 scale and summed for an overall quality of life score, with a high score representing higher quality of life. Baseline: last non-missing measurement prior to date of first microwave ablation or on date of first microwave ablation but prior to time of first probe placement. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Change From Baseline in EORTC QLQ HCC 18 Scale Score | Change from baseline in EORTC QLQ HCC 18 scale score were reported. EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) was an 18-multi-item scales which were grouped into 8 symptom scales such as fatigue, body image, jaundice, nutrition, pain, fever, abdominal swelling and sex life. All scales were grouped and converted to scores of 0 to 100 according to the scoring manual; a higher score represented a more severe symptom or problem. Baseline was defined as the last non-missing measurement taken prior to date of first microwave ablation (including unscheduled assessments) or on the date of first microwave ablation but prior to the time of first probe placement. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Pre-Ablation), Months 1, 3, 6, 9, 12, 18, 24, 30 and 36 (post ablation on Day 0) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Health Economics: Complete Procedure Time | Complete procedure time was defined as the time between the first probe placement and the last probe removal. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Median | Full Range | minutes | | Day 0 (On day of ablation treatment) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Health Economics: Total Ablation Duration | Total ablation duration were reported. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Median | Full Range | minutes | | Day 0 (On the day of ablation treatment) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Health Economics: Median Number of Ablations | The median number of ablations was reported. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Median | Full Range | ablations | | Day 0 (On the day of ablation treatment) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Health Economics: Length of Hospital Stay | Length of hospital stay were reported. Length of hospital stay was defined as the time from procedure completion to hospital discharge. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Median | Full Range | days | | Day 0 (On day of ablation treatment) up to 30 days (1-month post ablation visit) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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| Secondary | Health Economics: Percentage of Participants With Single and Multi Probes Usage | Percentage of participants with single and multiple probes usage were reported. PR and LK probes were used at least once. | FAS included all participants in whom the microwave ablation procedure was completed and who provided information on ablation margins for evaluation of technical success and technique efficacy. | Posted | | Number | | percentage of participants | | Day 0 (On the day of ablation treatment) | | | | ID | Title | Description |
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| OG000 | Microwave Ablation | Participants underwent microwave ablation using the NEUWAVE Certus 140 2.45 Gigahertz (GHz) Ablation System of liver tumors (Hepatocellular Carcinoma [HCC]) at a single visit, in accordance with their institution's standard-of-care (SOC) for ablation. The treating physician determined the ablation time and power used on a case-by-case basis. |
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