Clinical trial NCT04107766: NOLA (NeuWave Observational Liver Ablation) Registry
Official title: A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of the Liver
Liver Cancer
Neoplasms, Liver
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical success
timeFrame: Day of ablation (Day 0)
measure: Technical efficacy
timeFrame: 7 days to 3 months post-ablation
measure: Target lesion recurrence (local recurrence) rate
timeFrame: 5 years post-ablation
Secondary outcomes:
measure: Secondary efficacy rate
timeFrame: 5 years post-ablation
measure: Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s))
timeFrame: 5 years post-ablation
measure: Recurrence-free survival
timeFrame: 5 years post-ablation
measure: Overall survival
timeFrame: 5 years post-ablation
measure: Economic impact of ablation as evaluated by complete procedure duration
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Economic impact of ablation as evaluated by complete ablation duration
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Economic impact of ablation as evaluated by number of ablations
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Economic impact of ablation as evaluated by length of hospital stay
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Economic impact of ablation as evaluated by number of probes used
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Economic impact of ablation as evaluated by types of probes used
timeFrame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week
measure: Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs)
timeFrame: 5 years post-ablation
measure: Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18)
timeFrame: 9-12 months post-ablation
measure: Numeric Pain Rating Scale
timeFrame: 7 days to 3 months post-ablation
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Sylmar
country: United States
facility: Olive View UCLA
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin At Madison
state: Wisconsin
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Paris
country: France
facility: Tenon Hospital
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital (SNUBH)
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute (NKI)
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Goningen
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
References: