NCT03753789

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

October 31, 2018

Results QC Date

October 12, 2023

Last Update Submit

January 4, 2024

Conditions

Cancer of the LiverLiver CancerNeoplasms, Liver

Outcome Measures

Primary Outcomes (2)

  • Percentage of Lesions Where Probe Repositioning is Suggested

    Day 0

  • Percentage of Lesions Where Re-ablation is Suggested

    Day 0

Secondary Outcomes (3)

  • Technical Success

    Day 0

  • Technique Efficacy

    6 weeks

  • Hospital Resource Utilization

    6 weeks

Study Arms (1)

Microwave Ablation

EXPERIMENTAL

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

Interventions

Microwave AblationDEVICE

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.

Microwave Ablation

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Olives View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Erin Meyers
Organization
Ethicon
eprifog1@its.jnj.com
937-681-0322

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 27, 2018

Study Start

November 5, 2019

Primary Completion

October 12, 2022

Study Completion

October 12, 2022

Last Updated

January 5, 2024

Results First Posted

January 5, 2024

Record last verified: 2024-01

Locations

US(6)