Galvanize Pulsed Electric Field (PEF) treatment for soft tissue lesions
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Galvanize Therapeutics, Inc. Industry-sponsored |
| Locations | 10 sites (Gilbert, Arizona and 9 other locations) |
| Trial ID | NCT05851430 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gilbert, Arizona and 9 other locations
- 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)
- AnMed Health — Anderson, South Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.