Ablation Confirmation Study

Not Applicable

Terminated

• Conditions: Cancer of the Liver; Liver Cancer; Neoplasms, Liver
• Interventions: Device: Microwave Ablation

• Registration Number: NCT03753789
• Lead Sponsor: Ethicon, Inc.

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.

Study Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Study Start: 2019-11-05
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Results First Submitted: 2023-10-12
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Results First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microwave Ablation	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Lesions Where Probe Repositioning is Suggested	Day 0
Percentage of Lesions Where Re-ablation is Suggested	Day 0

Secondary Outcome Measures

Name	Time	Method
Hospital Resource Utilization	6 weeks	How many days patients remain in the hospital after the ablation procedure
Technical Success	Day 0	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)
Technique Efficacy	6 weeks	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

Trial Locations

Locations (6)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

UCLA; 🇺🇸 Los Angeles, California, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Olives View - UCLA Medical Center; 🇺🇸 Sylmar, California, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States