NCT05851430

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Galvanize Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Soft Tissue Lesion

Interventions

Type	Name	Description
DEVICE	PEF ablation	Pulsed Electric Field (PEF) Ablation per institutional standard of care

Timeline

• Start date: 2025-06-23
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2023-05-09
• Last updated: 2026-04-14

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study