Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry (PROPEL)

Galvanize Therapeutics

Status: Enrolling

Conditions: Soft Tissue Lesion

Treatments: Device: PEF ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT05851430

CSP-00017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Aliya PEF ablation

Description:

Patients will undergo PEF ablation per institutional standard of care

Treatment:

Device: PEF ablation