Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Not yet recruiting

• Conditions: Soft Tissue Lesion
• Interventions: Device: PEF ablation

• Registration Number: NCT05851430
• Lead Sponsor: Galvanize Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-01
• Primary Completion: 2028-06-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aliya PEF ablation	PEF ablation	Patients will undergo PEF ablation per institutional standard of care

Primary Outcome Measures

Name	Time	Method
PEF Target Size	PEF procedure	PEF target size (cm)
Anesthesia Type Usage for PEF Procedure	PEF procedure	Anesthesia type usage
PEF Target Location	PEF procedure	PEF procedural target location

Secondary Outcome Measures

Name	Time	Method
Incidence of SAEs	within 30 days of PEF energy delivery	Incidence of SAEs (Registry device and/or procedure related)
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events	within 30 days of PEF energy delivery	Unanticipated \[not listed in the Instructions for Use (IFU)\] adverse events (device-related)

Trial Locations

Locations (2)

Dayton VA Medical Center; 🇺🇸 Dayton, Ohio, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States