NOLA (NeuWave Observational Liver Ablation) Registry

NCT04107766 | Terminated Results FDA Device

• 1 other identifier: NEU_2017_04
• Study Type: observational
• Target: 1,254
• Locations: 8 countries
• Sites: 28

Brief 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.

Conditions

Cancer of the Liver; Liver Cancer; Neoplasms, Liver

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Overall Survival

  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.

Study Arms (1)

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

Interventions

Microwave Ablation DEVICE

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.

Population

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (28)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Olive View UCLA

Sylmar, California, 91342, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

ICAHN School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98101, United States

Location

University of Wisconsin At Madison

Madison, Wisconsin, 53792, United States

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200120, China

Location

Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

Tenon Hospital

Paris, 75020, France

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

VUMC Amsterdam

Amsterdam, 1081 HV, Netherlands

Location

University Medical Center Goningen

Groningen, 9713 GZ, Netherlands

Location

Radboud UMC

Nijmegen, 6525 GA, Netherlands

Location

Singapore General Hospital

Singapore, 168582, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Seoul National University Bundang Hospital (SNUBH)

Seongnam-si, Gyeonggi-do 13620, South Korea

Location

St. James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Erin Meyers
• Organization: Ethicon

eprifog1@its.jnj.com

937-681-0322

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 27, 2019
• Study Start: January 15, 2020
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (14); CN (2); KR (1); SG (2); GB (3); NL (3); FR (2)