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NCT05851430Recruiting

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Galvanize Therapeutics, Inc.

Start Date

6/23/2025

Completion Date

12/31/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: 1. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology 2. Subject is expected to be available for follow-up per the enrolling physician's standard care practices 3. 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 4. Signed informed consent is obtained, if required by IRB Exclusion Criteria: None

Interventions

DEVICE

PEF ablation

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Conditions

Soft Tissue Lesion

Locations

Banner Health

Gilbert, Arizona 85234

United States

Eisenhower Medical Center

Rancho Mirage, California 92270

United States

NCH Baker

Naples, Florida 34102

United States

New York Presbyterian Langone Health

New York, New York 10016

United States

Duke University Hospital

Durham, North Carolina 27705

United States

Lankenau Institute for Medical Research (LIMR)

Wynnewood, Pennsylvania 19096

United States

AnMed Health

Anderson, South Carolina 29621

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Methodist Hospital

San Antonio, Texas 78229

United States

University of Texas-Tyler

Tyler, Texas 75708

United States

West Virginia University

Morgantown, West Virginia 26506

United States