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Recruiting NCT05851430

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

— Observational Soft Tissue Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEF ablation.
Who it may be relevant to
Registry conditions: Soft Tissue Lesion. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are: * PEF utilization and performance * Monitor safety outcomes and inform future generation devices. Participants will undergo the PEF procedure and be followed per institutional standard of care.

Detailed description

This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology.

Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up.

Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.

Interventions

  • Device PEF ablation
    Pulsed Electric Field (PEF) Ablation per institutional standard of care

Primary outcome measures

  • Anesthesia Type Usage for PEF Procedure [Time frame: PEF procedure]
  • PEF Target Location [Time frame: PEF procedure]
  • PEF Target Size [Time frame: PEF procedure]
Secondary outcome measures (2)
  • Incidence of SAEs [Time frame: within 30 days of PEF energy delivery]
  • Unanticipated [not listed in the Instructions for Use (IFU)] adverse events [Time frame: within 30 days of PEF energy delivery]

Eligibility criteria

Inclusion criteria

  • Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
  • Subject is expected to be available for follow-up per the enrolling physician's standard care practices
  • For prospective cohort, subject has a life expectancy of at least 3 months; for retrospective cohort, subject has completed at least three months of imaging following the PEF procedure
  • Signed informed consent is obtained, if required by IRB

Exclusion criteria

None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 11 centers
  • Banner Health — Gilbert
  • Eisenhower Medical Center — Rancho Mirage
  • NCH Baker — Naples
  • New York Presbyterian Langone Health — New York
  • Duke University Hospital — Durham
  • Lankenau Institute for Medical Research (LIMR) — Wynnewood
  • AnMed Health — Anderson
  • UT Southwestern Medical Center — Dallas
  • … and 3 more centers

Identifiers

NCT: NCT05851430 · CSP-00017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗