Ablation Confirmation Study

A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cancer; Cancer of the Liver; Neoplasms, Liver
• Intervention / Treatment: Device: Microwave Ablation

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Meyers; Phone Number: 937-681-0322; Email: eprifog1@its.jnj.com
• Study Contact Backup: Name: Jaclyn Calia; Email: jcalia@its.jnj.com

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA
    • Sylmar, California, United States, 91342
      • Olives View - UCLA Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Lesions Where Probe Repositioning is Suggested	Day 0
Percentage of Lesions Where Re-ablation is Suggested	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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)	Day 0
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 (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) as assessed by imaging at 6 weeks	6 weeks
Hospital Resource Utilization	How many days patients remain in the hospital after the ablation procedure	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Confidence Questionnaire	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.	Day of ablation (day 0)
EORTC QLQ-C30	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').	6 weeks post-ablation
EORTC QLQ-HCC18	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').	6 weeks post-ablation
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 every study visit.	6 weeks post-ablation

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: NEU_2017_03

Drug and device information, study documents

• 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