Cancer of the LiverNCT04107766

NOLA (NeuWave Observational Liver Ablation) Registry

An observational study of Cancer of the Liver and Liver Cancer, run by Ethicon, Inc. at 28 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 22 years and older
Conditions the study is for: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
What is being tested?: Microwave Ablation
Type of treatment: Medical device
How many people: 1,254 participants
Where: 28 sitesin 8 countries
Study dates: 15 Jan 2020to 18 Jun 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study 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.

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

28 sites in 8 countries.

Country

City, postcode or hospital

28 sites in 8 countries

United States14 sites

University of Virginia
Charlottesville, Virginia, 22908
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Loma Linda University Medical Center
Loma Linda, California, 92354
Cedars Sinai Medical Center
Los Angeles, California, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
University of Wisconsin At Madison
Madison, Wisconsin, 53792
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Sutter Institute for Medical Research
Sacramento, California, 95816
Sarasota Memorial Hospital
Sarasota, Florida, 34239
University of Washington Medical Center
Seattle, Washington, 98101
Olive View UCLA
Sylmar, California, 91342

Other trials in United States

Netherlands3 sites

VUMC Amsterdam
Amsterdam, 1081 HV
University Medical Center Goningen
Groningen, 9713 GZ
Radboud UMC
Nijmegen, 6525 GA

Other trials in Netherlands

United Kingdom3 sites

St. James's University Hospital
Leeds, LS9 7TF
The Royal Marsden Hospital
London, SW3 6JJ
Norfolk and Norwich University Hospital
Norwich, NR4 7UY

Other trials in United Kingdom

China2 sites

The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200120

Other trials in China

France2 sites

Hôpital Européen Georges-Pompidou
Paris, 75015
Tenon Hospital
Paris, 75020

Other trials in France

Singapore2 sites

Singapore General Hospital
Singapore, 168582
Tan Tock Seng Hospital
Singapore, 308433

Other trials in Singapore

Germany1 site

University Hospital Regensburg
Regensburg, 93053

Other trials in Germany

South Korea1 site

Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, Gyeonggi-do 13620

Other trials in South Korea

About this study

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

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.

Read the detailed description

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.

Conditions: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Being tested: Microwave Ablation
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microwave AblationDevice
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.

Study groups in NCT04107766
Study group	Role	What they receive
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. Receives: Device: Microwave Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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.

Secondary outcomes (1)

Overall Survival
Overall survival was evaluated at every visit after ablation of the target lesion(s)
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202018 Jun 2025

First posted27 Sep 2019
Study start15 Jan 2020
Primary completion18 Jun 2025
Study completion18 Jun 2025

Why it stopped: Change in Company Strategy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cancer of the LiverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 1,254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04107766
Sponsor's protocol ID: NEU_2017_04
Status last verified: Apr 2026
First submitted: 5 Sep 2019
Last updated: 17 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
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RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
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CREO - Microwave Ablation Feasibility Study
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All Cancer of the Liver trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
ClinicalTrials.gov ID: NCT04107766
Acronym / sponsor ID: NEU_2017_04
Conditions: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Study type: Observational
Recruitment status: TerminatedReason stopped: Change in Company Strategy
Enrolment: 1,254 participants (actual)
Lead sponsor: Ethicon, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jan 2020 (actual)
Primary completion: 18 Jun 2025 (actual)
Study completion: 18 Jun 2025 (actual)
First posted: 27 Sep 2019 (actual)
Results: Posted 17 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Population	–	Device: Microwave AblationPatients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study 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.

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Microwave AblationPatients 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.	Device	Population

Primary outcome

Number of Patients Whose Ablation Resulted in Technical Success
Time frame: 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
Time frame: 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
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.
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.

1 secondary outcome

Overall Survival
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.

Results and safety

Results posted to the registry on 17 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Population	1,203	83

Primary outcome: Number of Patients Whose Ablation Resulted in Technical Success

Time frame: Immediately post-ablation (Day 0). Count of participants. Unit: Participants

Measure	Population n = 1198
Yes	1174
No	24

Population analysed: Technical Success outcome was reported for 1198 participants.

Primary outcome: Number of Patients Whose Ablation Resulted in Technique Efficacy

Time frame: Between 7 days and less than 3 months post-ablation. Count of participants. Unit: Participants

Measure	Population n = 1053
Yes	1000
No	53

Population analysed: Technique Efficacy outcome was reported for 1053 participants.

Primary outcome: Target Lesion Recurrence Rate

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.. Number (95% Confidence Interval). Unit: Percent Probability

Measure	Population n = 1203
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)

Population analysed: Kaplan-Meier probability of Target lesion recurrence at specified time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 years following the initial ablation procedure.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Population	488 of 1,203 (40.6%)	398 of 1,203 (33.1%)	213 of 1,203

Limitations and caveats (from the sponsor): The study planned to enroll up to 1500 patients, but was terminated early as the result of a business decision that was not safety related. At the time of early termination, 1254 patients had been enrolled, and 1203 patients had been treated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

Related trials for Cancer of the Liver

RecruitingObservational study
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The Vanguard Study: Testing a New Way to Screen for Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

28 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of the Liver and Liver Cancer, run by Ethicon, Inc. at 28 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Netherlands, United Kingdom, China, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Whose Ablation Resulted in Technical Success (time frame: Immediately post-ablation (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.