NOLA (NeuWave Observational Liver Ablation) Registry

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cancer; Cancer of the Liver; Neoplasms, Liver
• Intervention / Treatment: Device: Microwave Ablation

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.

• Study Type: Observational
• Enrollment (Actual): 1254

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200120
    • Renji Hospital, Shanghai Jiao Tong University School of Medicine
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital, Sun Yat-sen University
• France
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
  • Paris, France, 75020
    • Tenon Hospital
• Germany
  • Regensburg, Germany, 93053
    • University Hospital Regensburg
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VUMC Amsterdam
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Goningen
  • Nijmegen, Netherlands, 6525 GA
    • Radboud UMC
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 168582
    • Singapore General Hospital
• South Korea
  • Seongnam-si, South Korea, Gyeonggi-do 13620
    • Seoul National University Bundang Hospital (SNUBH)
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St. James's University Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research
    • Sylmar, California, United States, 91342
      • Olive View UCLA
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98101
      • University of Washington Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin at Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was evaluated at every visit after ablation of the target lesion(s)	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.

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: NEU_2017_04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes