NOLA (NeuWave Observational Liver Ablation) Registry

Liver Cancer Clinical Trial

Official title:

A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107766
• Other study ID #: NEU_2017_04
• Status: Recruiting
• Start date: January 15, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Ethicon, Inc.
• Contact: Jaclyn (Calia) Stanziola
• Phone: 908-218-2933
• Email: jcalia[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Liver
• Liver Cancer
• Liver Neoplasms
• Neoplasms, Liver

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
France	Hôpital Européen Georges-Pompidou	Paris
France	Tenon Hospital	Paris
Germany	University Hospital Regensburg	Regensburg
Korea, Republic of	Seoul National University Bundang Hospital (SNUBH)	Seongnam-si
Netherlands	Netherlands Cancer Institute (NKI)	Amsterdam
Netherlands	VUMC Amsterdam	Amsterdam
Netherlands	University Medical Center Goningen	Groningen
Netherlands	Radboud UMC	Nijmegen
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
United Kingdom	St. James's University Hospital	Leeds
United Kingdom	The Royal Marsden Hospital	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United States	University of Virginia	Charlottesville	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	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	University of Wisconsin At Madison	Madison	Wisconsin
United States	University of Miami, Miller School of Medicine	Miami	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	Sutter Institute for Medical Research	Sacramento	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	University of Washington Medical Center	Seattle	Washington
United States	Olive View UCLA	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  China,  France,  Germany,  Korea, Republic of,  Netherlands,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	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.	Day of ablation (Day 0)
Primary	Technical efficacy	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).	7 days to 3 months post-ablation
Primary	Target lesion recurrence (local recurrence) rate	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.	5 years post-ablation
Secondary	Secondary efficacy rate	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.	5 years post-ablation
Secondary	Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s))	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.	5 years post-ablation
Secondary	Recurrence-free survival	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.	5 years post-ablation
Secondary	Overall survival	Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up.	5 years post-ablation
Secondary	Economic impact of ablation as evaluated by complete procedure duration		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Economic impact of ablation as evaluated by complete ablation duration		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Economic impact of ablation as evaluated by number of ablations		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Economic impact of ablation as evaluated by length of hospital stay		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Economic impact of ablation as evaluated by number of probes used		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Economic impact of ablation as evaluated by types of probes used		Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
Secondary	Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs)	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.	5 years post-ablation
Secondary	Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18)	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.	9-12 months post-ablation
Secondary	Numeric Pain Rating Scale	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).	7 days to 3 months post-ablation