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NOLA (NeuWave Observational Liver Ablation) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04107766
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 27, 2019
Last Update Posted Date May 3, 2023
Actual Study Start Date January 15, 2020
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2020)
  • Technical success [ Time Frame: 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 [ Time Frame: 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).
  • Target lesion recurrence (local recurrence) rate [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: September 26, 2019)
  • Technical success [ Time Frame: 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 [ Time Frame: 7 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).
  • Target lesion recurrence rate [ Time Frame: 5 years post-ablation ]
    Target lesion 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.
Change History
Current Secondary Outcome Measures
 (submitted: August 31, 2021)
  • Secondary efficacy rate [ Time Frame: 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)) [ Time Frame: 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.
  • Recurrence-free survival [ Time Frame: 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 [ Time Frame: 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 procedure duration [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by complete ablation duration [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by number of ablations [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by length of hospital stay [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by number of probes used [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by types of probes used [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs) [ Time Frame: 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.
  • Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18) [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures
 (submitted: September 26, 2019)
  • Secondary efficacy rate [ Time Frame: 5 years post-ablation ]
    Secondary efficacy rate, defined as the percentage of soft tissue lesions that have undergone successful repeat ablations following identification of local soft tissue lesion progression, as assessed by CT, MRI, PET, US, and/or X-ray.
  • Recurrence-free survival [ Time Frame: 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 [ Time Frame: 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 procedure duration [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Incidence of reportable Adverse Events/Serious Adverse Events (AEs/SAEs) [ Time Frame: 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.
  • Numeric Pain Rating Scale [ Time Frame: 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 every study visit through 7 days to 3 months post-ablation.
  • Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18) [ Time Frame: 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 each study visit up to 9-12 months post-ablation.
  • Economic impact of ablation as evaluated by complete ablation duration [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by number of ablations [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by length of hospital stay [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
  • Economic impact of ablation as evaluated by number and types of probes used [ Time Frame: Day of ablation (Day 0) through hospital discharge, estimated up to 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cancer of the Liver
  • Liver Cancer
  • 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.
Study Groups/Cohorts 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.
Intervention: Device: Microwave Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2019)		 1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2027
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jaclyn (Calia) Stanziola 908-218-2933 jcalia@its.jnj.com
Contact: Julie Peveto 908-218-3659 jpeveto@its.jnj.com
Listed Location Countries France,   Germany,   Korea, Republic of,   Netherlands,   Singapore,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04107766
Other Study ID Numbers NEU_2017_04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
URL: http://yoda.yale.edu
Current Responsible Party Ethicon, Inc.
Original Responsible Party Same as current
Current Study Sponsor Ethicon, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Ethicon, Inc.
Verification Date May 2023