Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Justin McWilliams, MDThomas Le, MD

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 up to 1,500 patients throughout the world who underwent or are scheduled to undergo 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.
  2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation.
  3. Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver. Note: roll-over patients from previous NeuWave trials are permitted.

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • Olive View UCLA accepting new patients
    Sylmar California 91342 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientists at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ethicon, Inc.
Links
Sign up for this study
ID
NCT04107766
Study Type
Observational
Participants
Expecting 1500 study participants
Last Updated