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Ablation Confirmation Study

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ClinicalTrials.gov Identifier: NCT03753789
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of the Liver Liver Cancer Neoplasms, Liver Device: Microwave Ablation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : October 29, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Microwave Ablation
NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
 Device: Microwave Ablation
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients where probe repositioning is suggested [ Time Frame: Day of ablation (day 0) ]
    The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.

  2. Percentage of patients where re-ablation is suggested [ Time Frame: Day of ablation (day 0) ]
    The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.


Secondary Outcome Measures :
  1. Rate of Adverse Events [ Time Frame: 6 weeks post-ablation ]
    Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.

  2. Technical Success [ Time Frame: Day of ablation (day 0) ]
    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.

  3. Technique Efficacy [ Time Frame: 6 weeks post-ablation ]
    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.

  4. Hospital Resource Utilization #1: Time to perform the ablation procedure, [ Time Frame: Day of ablation (day 0) ]
    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

  5. Hospital Resource Utilization #2: Length of hospital stay (if applicable) [ Time Frame: 6 weeks post-ablation ]

    The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):

    Length of hospital stay (if applicable)



Other Outcome Measures:
  1. Physician Confidence Questionnaire [ Time Frame: Day of ablation (day 0) ]
    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.

  2. EORTC QLQ-C30 [ Time Frame: 6 weeks post-ablation ]
    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').

  3. EORTC QLQ-HCC18 [ Time Frame: 6 weeks post-ablation ]
    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').

  4. Numeric Pain Rating Scale [ Time Frame: 6 weeks 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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
  3. Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor
  4. Patients greater than or equal to 22 years of age
  5. Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification
  6. Class A or B functional hepatic reserve based on the Child-Pugh score.
  7. 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:

  1. Active bacterial infection or fungal infection on the day of the ablation.
  2. Patients with implantable pacemakers or other electronic implants.
  3. Platelet count less than 50,000/mm cubed.
  4. Patients with uncorrectable coagulopathy at the time of ablation.
  5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
  6. Physical or psychological condition which would impair study participation.
  7. ASA (American Society of Anesthesiologists) score of great or equal to 4.
  8. Use of hydrodissection.
  9. Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
  10. INR greater than 1.8.
  11. Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
  12. Patient judged unsuitable for study participation by the performing physician for any other reason.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753789


Contacts
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Contact: Erin Meyers 937-681-0322 eprifog1@its.jnj.com
Contact: Jaclyn Calia jcalia@its.jnj.com

Locations
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United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Ashley Wachsman         
Principal Investigator: Ashley Wachsman         
UCLA Recruiting
Los Angeles, California, United States, 90095
Olives View - UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Matthew Callstrom         
Principal Investigator: Matthew Callstrom         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Constantinos Sofocleous         
Principal Investigator: Constantinos Sofocleous         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Bruno Odisio         
Principal Investigator: Bruno Odisio         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Timothy Ziemlewicz         
Principal Investigator: Timothy Ziemlewicz         
Sponsors and Collaborators
Ethicon, Inc.
More Information
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Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT03753789    
Other Study ID Numbers: NEU_2017_03
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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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
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases