Study of Galvanize Pulsed Electric Field Device for Soft Tissue Lesions Observing Use, Safety, and Performance Over 2 Years

What this Trial Is About

Researchers are observing the use and performance of Galvanize Pulsed Electric Field PEF technology in treating soft tissue lesions in a real-world setting. This multi-center registry study aims to answer key questions about how PEF technology is used, its performance, and safety outcomes to help develop future device generations. Up to 200 patients who undergo or have undergone PEF procedures will be enrolled across the United States. Participants receive the PEF ablation procedure following their institutions standard care practices. The study includes both prospective enrollment, where patients will be followed for 2 years after the PEF procedure, and retrospective enrollment, where patients who already had the procedure are followed longitudinally. This observational registry does not involve experimental treatment but monitors routine clinical use of the device. During the study, participants will be monitored according to their usual care schedules, with follow-up visits as determined by their physicians. Researchers will collect information on anesthesia type used during the PEF procedure, target location and size of the ablation, and track any serious or unexpected adverse events within 30 days after treatment. The total follow-up duration for participants is 2 years, allowing long-term assessment of safety and device performance.

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry