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Recruiting NCT05851430

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Conditions: Soft Tissue Lesion

Sponsor: Galvanize Therapeutics, Inc.

trial.available_in: БГ
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.
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.
Who can participate
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
PEF ablation
DEVICE
Locations 10
United States (10)
AnMed Health
Anderson , South Carolina
UT Southwestern Medical Center
Dallas , Texas
Duke University Hospital
Durham , North Carolina
Banner Health
Gilbert , Arizona
West Virginia University
Morgantown , West Virginia
NCH Baker
Naples , Florida
Yanna Prishchepa, RN
New York Presbyterian Langone Health
New York , New York
Eisenhower Medical Center
Rancho Mirage , California
University of Texas-Tyler
Tyler , Texas
Lankenau Institute for Medical Research (LIMR)
Wynnewood , Pennsylvania
Jessica Burrell, BA, BS, CCRP
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
23.06.2025
Completion date
31.12.2028
Registry ID
NCT05851430
Source
clinicaltrials.gov
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