Ablation Confirmation Study

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03753789
• Other study ID #: NEU_2017_03
• Status: Terminated
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: October 12, 2022

Study information

• Verified date: January 2024
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Liver
• Liver Cancer
• Liver Neoplasms
• Neoplasms, Liver

Intervention

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	UCLA	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota
United States	Olives View - UCLA Medical Center	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Lesions Where Probe Repositioning is Suggested		Day 0
Primary	Percentage of Lesions Where Re-ablation is Suggested		Day 0
Secondary	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
Secondary	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
Secondary	Hospital Resource Utilization	How many days patients remain in the hospital after the ablation procedure	6 weeks