Actively Recruiting
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Led by Galvanize Therapeutics, Inc. · Updated on 2026-04-23
1000
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the use and performance of the Galvanize Pulsed Electric Field (PEF) technology in real-world settings for patients with soft tissue lesions. The study aims to understand how often and how well the PEF technology is used, monitor safety outcomes, and provide information to improve future versions of the device. This observational registry includes patients who have undergone or are scheduled to undergo PEF ablation. Participants will receive PEF ablation treatment according to their institution's standard care practices. The study follows patients either prospectively or retrospectively, with a total follow-up period of two years starting from their PEF procedure date. Up to 200 patients across the US will be enrolled, and their treatments will be monitored but not altered by the study. During the study, participants will be followed according to their usual care plans, with researchers collecting information on the type of anesthesia used, the target location and size of the PEF treatment area, and any serious or unexpected adverse events within 30 days after the procedure. The study will track outcomes through imaging and standard follow-up visits as determined by the treating physician. Participants will be involved for up to two years to gather long-term safety and performance data on the device.
CONDITIONS
Brief Title
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo Pulsed Electric Field (PEF) ablation per institutional standard of care.
1 visit (in-person)
Duration - Up to 2 years
Participants are followed for up to 2 years following the PEF procedure to monitor outcomes and any adverse events.
Follow-up visits as per institutional standard of care
Trial Site Locations
Total: 10 locations
1
Banner Health
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Actively Recruiting
3
NCH Baker
Naples, Florida, United States, 34102
Actively Recruiting
4
New York Presbyterian Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
Duke University Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
6
Lankenau Institute for Medical Research (LIMR)
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
7
AnMed Health
Anderson, South Carolina, United States, 29621
Actively Recruiting
8
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
9
University of Texas-Tyler
Tyler, Texas, United States, 75708
Actively Recruiting
10
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
P
Partha Seshaiah, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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