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NCT Number: NCT05851430

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

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.

Recruiting

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Key information

Conditions

Soft Tissue Lesion

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner Health, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
  • Subject is expected to be available for follow-up per the enrolling physician's standard care practices
  • 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
  • Signed informed consent is obtained, if required by IRB

Exclusion criteria

None

Treatment and study plan

PEF ablation

Device

Pulsed Electric Field (PEF) Ablation per institutional standard of care

Primary outcomes

  1. Anesthesia Type Usage for PEF Procedure

    Time frame: PEF procedure

    Anesthesia type usage

  2. PEF Target Location

    Time frame: PEF procedure

    PEF procedural target location

  3. PEF Target Size

    Time frame: PEF procedure

    PEF target size (cm)

Secondary outcomes

  1. Incidence of SAEs

    Time frame: within 30 days of PEF energy delivery

    Incidence of SAEs (Registry device and/or procedure related)

  2. Unanticipated [not listed in the Instructions for Use (IFU)] adverse events

    Time frame: within 30 days of PEF energy delivery

    Unanticipated [not listed in the Instructions for Use (IFU)] adverse events (device-related)

Study contacts

Contact information is provided by the study sponsor or research team.

Partha Seshaiah, PhD

CONTACT

[email protected]

650-268-4252

Sponsors and collaborators

Lead sponsor

Galvanize Therapeutics, Inc.

Industry

Registry information

Acronym: PROPEL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 9, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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