Registry for patients undergoing microwave ablation for liver cancer
A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
This study is tracking up to 1,500 patients who have had microwave ablation for liver cancer to see how well the treatment works and to improve future care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Ethicon, Inc. Industry-sponsored |
| Locations | 30 sites (Loma Linda, California and 29 other locations) |
| Trial ID | NCT04107766 on ClinicalTrials.gov |
What this trial studies
This multicenter observational registry follows patients for five years after their first liver ablation procedure using the NEUWAVE Microwave Ablation System. It collects data from various participating sites to analyze and develop guidance on ablation parameters tailored to different liver tissue conditions and lesions. The registry includes both prospective and retrospective patient data, aiming to enroll up to 1,500 patients worldwide who have undergone or are scheduled for this treatment.
Who should consider this trial
Good fit: Ideal candidates are patients aged 22 and older who are undergoing microwave ablation for liver lesions using the NEUWAVE system.
Not a fit: Patients with a life expectancy of less than one year or those using microwave ablation solely as a transection tool may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of microwave ablation techniques, leading to improved treatment outcomes for liver cancer patients.
How similar studies have performed: Other studies utilizing observational registries for similar ablation techniques have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 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: 1. Patients with a life expectancy of less than 1 year, in the opinion of the treating physician. 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.
Where this trial is running
Loma Linda, California and 29 other locations
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States (Recruiting)
- Sutter Institute for Medical Research — Sacramento, California, United States (Recruiting)
- Olive View UCLA — Sylmar, California, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- University of Miami, Miller School of Medicine — Miami, Florida, United States (Withdrawn)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
- ICAHN School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
- University of Wisconsin At Madison — Madison, Wisconsin, United States (Recruiting)
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Enrolling_by_invitation)
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Enrolling_by_invitation)
- Hôpital Européen Georges-Pompidou — Paris, France (Recruiting)
- Tenon Hospital — Paris, France (Terminated)
- University Hospital Regensburg — Regensburg, Germany (Recruiting)
- Seoul National University Bundang Hospital (SNUBH) — Seongnam-si, Korea, Republic of (Active_not_recruiting)
- Netherlands Cancer Institute (NKI) — Amsterdam, Netherlands (Withdrawn)
- VUMC Amsterdam — Amsterdam, Netherlands (Recruiting)
- University Medical Center Goningen — Groningen, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Singapore General Hospital — Singapore, Singapore (Recruiting)
- Tan Tock Seng Hospital — Singapore, Singapore (Terminated)
- St. James's University Hospital — Leeds, United Kingdom (Recruiting)
- The Royal Marsden Hospital — London, United Kingdom (Recruiting)
- Norfolk and Norwich University Hospital — Norwich, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Erin Meyers
- Email: eprifog1@its.jnj.com
- Phone: 1 908 8086302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.