Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Thomas Le (ucla)

Description

Summary

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

Official Title

A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

Details

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions.

This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up.

Enrollment for this study will include at least 1,500 patients throughout the world who underwent or are undergoing microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.

Keywords

Cancer of the Liver Liver Cancer Neoplasms, Liver Liver Neoplasms Microwave Ablation Population

Eligibility

You can join if…

Open to people ages 22 years and up

  1. Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU).
  2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database.
  3. Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC).

You CAN'T join if...

1) Patients with a life expectancy of less than 1 year, in the opinion of the treating physician.

Locations

  • Olive View UCLA accepting new patients
    Sylmar California 91342 United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda California 92354 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ethicon, Inc.
ID
NCT04107766
Study Type
Observational
Last Updated