Galvanize Pulsed Electric Field (PEF) treatment for soft tissue lesions
Official title: Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Run by Galvanize Therapeutics, Inc. · NCT05851430 · Data updated 2026-11-12
This registry follows people with soft tissue lesions who receive Galvanize pulsed electric field (PEF) treatment to see how the device is used, whether it works, and whether it's safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Galvanize Therapeutics, Inc. Industry-sponsored |
| Locations | 11 sites (Gilbert, Arizona and 10 other locations) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT05851430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with soft tissue lesions who have undergone or are scheduled to undergo Galvanize PEF treatment, can be followed according to their treating physician's standard care, and meet the minimal follow-up or life-expectancy criteria for prospective or retrospective enrollment.
✕Probably not a fit
Patients who are not treated with Galvanize PEF, who have conditions outside the targeted soft tissue lesions, or who cannot complete follow-up are unlikely to gain useful information from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center observational registry enrolling up to 200 patients who have undergone or are scheduled to undergo PEF ablation with the FDA-cleared Galvanize system. Participants may be entered retrospectively or enrolled prospectively and will be followed per each site's standard of care for a total of two years after the PEF procedure. The registry collects real-world data on device utilization, performance outcomes, and safety events. Findings are intended to inform clinical use and future device iterations.
Why it matters
Potential benefit: If successful, the registry could provide clearer real-world evidence on Galvanize PEF safety and performance to help clinicians and patients make informed treatment decisions and guide device improvements.
How similar studies have gone: Some prior PEF device programs and small studies have shown promising safety and lesion-control signals, but large multi-center registries specifically for Galvanize technology are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Banner Health
Gilbert, Arizona, United States Recruiting -
Eisenhower Medical Center
Rancho Mirage, California, United States Recruiting -
NCH Baker
Naples, Florida, United States Recruiting -
New York Presbyterian Langone Health
New York, New York, United States Recruiting -
Duke University Hospital
Durham, North Carolina, United States Recruiting -
Lankenau Institute for Medical Research (LIMR)
Wynnewood, Pennsylvania, United States Recruiting
Show 5 more locations
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AnMed Health
Anderson, South Carolina, United States Recruiting -
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting -
Methodist Hospital
San Antonio, Texas, United States Recruiting -
University of Texas-Tyler
Tyler, Texas, United States Recruiting -
West Virginia University
Morgantown, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Partha Seshaiah, PhD
- Email: pseshaiah@galvanizetx.com
- Phone: 650-268-4252
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.