Back to resultsAblation Confirmation Study
Primary Purpose
Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microwave Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of the Liver
Eligibility Criteria
Inclusion Criteria:
- A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure.
- Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
- Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
- Patients greater than or equal to 22 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification
- Class A or B functional hepatic reserve based on the Child-Pugh score.
- Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).
Exclusion Criteria:
- Active bacterial infection or fungal infection on the day of the ablation.
- Patients with implantable pacemakers or other electronic implants.
- Platelet count less than 50,000/mm cubed.
- Patients with uncorrectable coagulopathy at the time of ablation.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of great or equal to 4.
- Use of hydrodissection.
- Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
- INR greater than 1.8.
- Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
- Patient judged unsuitable for study participation by the performing physician for any other reason.
Sites / Locations
- Loma Linda University Medical Center
- UCLA
- Olives View - UCLA Medical Center
- Mayo Clinic
- MD Anderson Cancer Center
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microwave Ablation
Arm Description
NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
Outcomes
Primary Outcome Measures
Percentage of patients where probe repositioning is suggested
The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.
Percentage of patients where re-ablation is suggested
The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.
Secondary Outcome Measures
Rate of Adverse Events
Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.
Technical Success
Technical Success is 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 (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure.
Technique Efficacy
Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging.
Hospital Resource Utilization #1: Time to perform the ablation procedure,
The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation
Hospital Resource Utilization #2: Length of hospital stay (if applicable)
The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):
Length of hospital stay (if applicable)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03753789
Brief Title
Ablation Confirmation Study
Official Title
A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Combined study endpoints with ongoing registry (NOLA/NEU_2017_04)
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
Detailed Description
Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin.
All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Liver, Liver Cancer, Neoplasms, Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
Intervention Type
Device
Intervention Name(s)
Microwave Ablation
Intervention Description
NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
Primary Outcome Measure Information:
Title
Percentage of patients where probe repositioning is suggested
Description
The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.
Time Frame
Day of ablation (day 0)
Title
Percentage of patients where re-ablation is suggested
Description
The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.
Time Frame
Day of ablation (day 0)
Secondary Outcome Measure Information:
Title
Rate of Adverse Events
Description
Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.
Time Frame
6 weeks post-ablation
Title
Technical Success
Description
Technical Success is 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 (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure.
Time Frame
Day of ablation (day 0)
Title
Technique Efficacy
Description
Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging.
Time Frame
6 weeks post-ablation
Title
Hospital Resource Utilization #1: Time to perform the ablation procedure,
Description
The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation
Time Frame
Day of ablation (day 0)
Title
Hospital Resource Utilization #2: Length of hospital stay (if applicable)
Description
The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):
Length of hospital stay (if applicable)
Time Frame
6 weeks post-ablation
Other Pre-specified Outcome Measures:
Title
Physician Confidence Questionnaire
Description
A non-validated 5-point scale (0 meaning 'strongly disagree' and 5 meaning 'strongly agree') questionnaire containing 5 questions for the treating physician asking their confidence in completeness of the ablation before using AC compared to after using AC.
Time Frame
Day of ablation (day 0)
Title
EORTC QLQ-C30
Description
European Organization for Research and Treatment of Cancer quality of life questionnaire containing 30 questions aimed at cancer patients. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
Time Frame
6 weeks post-ablation
Title
EORTC QLQ-HCC18
Description
European Organization for Research and Treatment of Cancer quality of life questionnaire containing 18 questions aimed at patients with primary liver cancer. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
Time Frame
6 weeks post-ablation
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
6 weeks post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure.
Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
Patients greater than or equal to 22 years of age
Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification
Class A or B functional hepatic reserve based on the Child-Pugh score.
Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).
Exclusion Criteria:
Active bacterial infection or fungal infection on the day of the ablation.
Patients with implantable pacemakers or other electronic implants.
Platelet count less than 50,000/mm cubed.
Patients with uncorrectable coagulopathy at the time of ablation.
Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
Physical or psychological condition which would impair study participation.
ASA (American Society of Anesthesiologists) score of great or equal to 4.
Use of hydrodissection.
Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
INR greater than 1.8.
Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
Patient judged unsuitable for study participation by the performing physician for any other reason.
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Olives View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Ablation Confirmation Study
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