NOLA (NeuWave Observational Liver Ablation) Registry

Last updated: July 6, 2025
Sponsor: Ethicon, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Liver Disease

Liver Cancer

Digestive System Neoplasms

Treatment

Microwave Ablation

Clinical Study ID

NCT04107766
NEU_2017_04
  • Ages > 22
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who underwent or are scheduled to undergo a microwave ablation of one ormore liver lesions with the NEUWAVE Microwave Ablation System per the device'sInstructions for Use (IFU).

  2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willingto comply with the assessment schedule, and willing to have data included in thedatabase.

  3. Patients greater than or equal to 22 years old at the time of informed consent (orwaiver approved by IRB/EC).

Exclusion

Exclusion Criteria:

  1. Patients with a life expectancy of less than 1 year, in the opinion of the treatingphysician.

  2. Use of microwave ablation purely as a transection tool, rather than focused liverlesion ablation.

  3. Patient is currently participating, or planning to participate, in anotherNeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in theliver. Note: roll-over patients from previous NeuWave trials are permitted.

Study Design

Total Participants: 1255
Treatment Group(s): 1
Primary Treatment: Microwave Ablation
Phase:
Study Start date:
January 15, 2020
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200120
    China

    Site Not Available

  • Hôpital Européen Georges-Pompidou

    Paris, 75015
    France

    Site Not Available

  • Tenon Hospital

    Paris, 75020
    France

    Site Not Available

  • University Hospital Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Seoul National University Bundang Hospital (SNUBH)

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Netherlands Cancer Institute (NKI)

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • VUMC Amsterdam

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • University Medical Center Goningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Singapore General Hospital

    Singapore, 168582
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • St. James's University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Sutter Institute for Medical Research

    Sacramento, California 95816
    United States

    Site Not Available

  • Olive View UCLA

    Sylmar, California 91342
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami, Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • ICAHN School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • University of Wisconsin At Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

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