Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
1255 participants
OBSERVATIONAL
2020-01-15
2025-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics
NCT05471596
Radiofrequency Versus Laser Ablation for Hepatocellular Carcinoma
NCT01096914
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
NCT04123340
Laparoscopic Microwave Ablation and Portal Vein Ligation for Staged Hepatectomy (LAPS)
NCT02184182
Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging
NCT04705194
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC).
Exclusion Criteria
2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation.
3. 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.
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ethicon, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Loma Linda University Medical Center
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Olive View UCLA
Sylmar, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin At Madison
Madison, Wisconsin, United States
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Hôpital Européen Georges-Pompidou
Paris, , France
Tenon Hospital
Paris, , France
University Hospital Regensburg
Regensburg, , Germany
VUMC Amsterdam
Amsterdam, , Netherlands
University Medical Center Goningen
Groningen, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, , South Korea
St. James's University Hospital
Leeds, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEU_2017_04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.