An observational study in Cancer of the Liver, Liver Cancer and Neoplasms, Liver, sponsored by Ethicon, Inc.. Terminated at 28 sites in 8 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Ethicon, Inc. (part of Johnson & Johnson) · Observational
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.
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.
1,345 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.
This study's enrollment of 1,254 is above the median of 200 across 342 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Number of Patients Whose Ablation Resulted in Technical Success
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.
Time frame: Immediately post-ablation (Day 0)
Number of Patients Whose Ablation Resulted in Technique Efficacy
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).
Time frame: Between 7 days and less than 3 months post-ablation
Target Lesion Recurrence Rate
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.
Time frame: 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.
Overall Survival
Overall survival was evaluated at every visit after ablation of the target lesion(s)
Time frame: 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.
1254 participants enrolled in the study. 1 participant withdrew from the study, 1 participant discontinued, and 49 of these participants were later screen failures as they did not meet all inclusion/exclusion criteria. 1203 participants were treated with the NeuWave microwave ablation device.
| Milestone | Population |
|---|---|
| Started | 1203 |
| Completed | 83 |
| Not completed | 1120 |
| Withdrew: Study stopped by sponsor | 750 |
| Withdrew: Adverse event | 3 |
| Withdrew: Death | 213 |
| Withdrew: Lost to follow-up | 53 |
| Withdrew: Physician decision | 9 |
| Withdrew: Site closed by sponsor | 12 |
| Withdrew: Withdrawal by subject | 18 |
| Withdrew: Other | 62 |
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.
| Participants | Population |
|---|---|
| Yes | 1174 |
| No | 24 |
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).
| Participants | Population |
|---|---|
| Yes | 1000 |
| No | 53 |
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.
| Percent Probability | Population |
|---|---|
| At 6 month follow up | 4.69 (3.51 to 6.25) |
| At 12 month follow up | 10.05 (8.24 to 12.23) |
| At 18 month follow up | 14.36 (12.12 to 16.98) |
| At 24 month follow up | 17.14 (14.63 to 20.04) |
| At 30 month follow up | 19.94 (17.09 to 23.19) |
| At 36 month follow up | 21.44 (18.39 to 24.92) |
| At 42 month follow up | 25.52 (21.73 to 29.84) |
| At 48 month follow up | 27.42 (23.22 to 32.20) |
| At 54 month follow up | 29.72 (24.72 to 35.47) |
| At 60 month follow up | 31.57 (26.71 to 38.38) |
Overall survival was evaluated at every visit after ablation of the target lesion(s)
| Percent Probability | Population |
|---|---|
| At 6 month follow up | 98.27 (97.34 to 98.88) |
| At 12 month follow up | 95.12 (93.66 to 96.25) |
| At 18 month follow up | 89.96 (87.91 to 91.69) |
| At 24 month follow up | 84.66 (82.14 to 86.84) |
| At 30 month follow up | 81.42 (78.65 to 83.87) |
| At 36 month follow up | 77.77 (74.69 to 80.53) |
| At 42 month follow up | 74.86 (71.44 to 77.94) |
| At 48 month follow up | 71.50 (67.51 to 75.09) |
| At 54 month follow up | 68.14 (63.25 to 72.52) |
| At 60 month follow up | 68.14 (63.25 to 72.52) |
Collected over 5 years following the initial ablation procedure.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Population | 213/1,203 (17.7%) | 488/1,203 (40.6%) | 398/1,203 (33.1%) |
| Event | Population |
|---|---|
| Death of unknown causeGeneral disorders | 51/1203 |
| PyrexiaGeneral disorders | 36/1203 |
| Hepatic encephalopathyNervous system disorders | 31/1203 |
| Abdominal painGastrointestinal disorders | 27/1203 |
| Acute kidney injuryRenal and urinary disorders | 27/1203 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 23/1203 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 20/1203 |
| SepsisInfections and infestations | 18/1203 |
| PneumoniaInfections and infestations | 17/1203 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 17/1203 |
| Event | Population |
|---|---|
| Procedural painInjury, poisoning and procedural complications | 107/1203 |
| Abdominal painGastrointestinal disorders | 99/1203 |
| NauseaGastrointestinal disorders | 53/1203 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 50/1203 |
| PyrexiaGeneral disorders | 31/1203 |
| Abdominal pain upperGastrointestinal disorders | 30/1203 |
| Wound secretionInjury, poisoning and procedural complications | 28/1203 |
1203 participants underwent NEUWAVE microwave ablation, with or without Ablation Confirmation software, of at least one soft-tissue liver lesion in accordance with the study site's standard-of-care.
| Age, Continuous(Years) | Population |
|---|---|
| Mean | 64.4 ± 10.7 |
| Sex: Female, Male(Participants) | Population |
|---|---|
| Female | 376 |
| Male | 827 |
| Ethnicity (NIH/OMB)(Participants) | Population |
|---|---|
| Hispanic or Latino | 76 |
| Not Hispanic or Latino | 929 |
| Unknown or Not Reported | 198 |
| Race/Ethnicity, Customized(Participants) | Population |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 238 |
| Black or African American | 34 |
| Native Hawaiian or Other Pacific Islander | 2 |
| White | 751 |
| Multiple | 2 |
| Not Reported | 141 |
| Other | 32 |
| Number of Target Lesions per Participant(Participants) | Population |
|---|---|
| 1 Lesion | 970 |
| 2 Lesions | 158 |
| 3 Lesions | 55 |
| 4 Lesions | 12 |
| 5 or More Lesions | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Data sharing details ↗ · yoda.yale.edu
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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