NOLA (NeuWave Observational Liver Ablation) Registry

Terminated

• Conditions: Liver Cancer; Neoplasms, Liver; Cancer of the Liver

• Registration Number: NCT04107766
• Lead Sponsor: Ethicon, Inc.

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.

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 Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2020-01-15
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-06
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1255

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion recurrence (local recurrence) rate	5 years post-ablation	Target lesion recurrence (local recurrence) rate is evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.
Technical success	Day of ablation (Day 0)	Technical success, defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e. the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
Technical efficacy	7 days to 3 months post-ablation	Technique efficacy, ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e., the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, at Visit 3 (between 7 days and less than 3 months post-ablation).

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy rate	5 years post-ablation	Secondary efficacy rate, defined as the percentage of soft tissue lesions that have undergone successful repeat ablations (target or non-target) following identification of local soft tissue lesion progression, as assessed by CT, MRI, PET, US, and/or X-ray. A successful repeat ablation will be defined as ablation of the lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e. the ablation zone completely overlaps or encompasses the lesion plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s))	5 years post-ablation	Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s)), evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.
Economic impact of ablation as evaluated by complete procedure duration	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs)	5 years post-ablation	Incidence of adverse events (AEs) (SAEs) that are deemed at least unlikely related to the procedure or device and all serious adverse events (SAEs) from day of ablation through the end of the study.
Recurrence-free survival	5 years post-ablation	Recurrence-free survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.
Overall survival	5 years post-ablation	Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up.
Economic impact of ablation as evaluated by complete ablation duration	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Economic impact of ablation as evaluated by number of ablations	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Economic impact of ablation as evaluated by number of probes used	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Economic impact of ablation as evaluated by types of probes used	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18)	9-12 months post-ablation	European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and liver-specific QLQ-HCC18 are questionnaires that will be completed at the Ablation Visit (pre-ablation), and each study visit afterwards, up to 9-12 months post-ablation.; Note: These two questionnaires were chosen as tools to assess overall health status/quality of life in the patient population with soft-tissue liver lesions.
Numeric Pain Rating Scale	7 days to 3 months post-ablation	The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at the Ablation Visit (pre- and post-ablation), and at the first study visit after the ablation (7 days to 3 months post-ablation).
Economic impact of ablation as evaluated by length of hospital stay	Day of ablation (Day 0) through hospital discharge, estimated up to 1 week

Trial Locations

Locations (28)

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

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