Ablation Confirmation Study

• ClinicalTrials.gov Identifier: NCT03753789
• Recruitment Status: Terminated
• First Posted: November 27, 2018
• Last Update Posted: January 6, 2023
• Sponsor: Ethicon, Inc.
• Information provided by (Responsible Party): Ethicon, Inc.

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.

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 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
• Actual Primary Completion Date: October 12, 2022
• Actual Study Completion Date: October 12, 2022

Arms and Interventions

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

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

• 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

Locations

United States, California

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

UCLA

Los Angeles, California, United States, 90095

Olives View - UCLA Medical Center

Sylmar, California, United States, 91342

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55902

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Ethicon, Inc.

More Information

• Responsible Party: Ethicon, Inc.
• ClinicalTrials.gov Identifier: NCT03753789
• Other Study ID Numbers: NEU_2017_03
• First Posted: November 27, 2018
• Last Update Posted: January 6, 2023
• Last Verified: December 2022

• 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:

Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases