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

April 22, 2026 updated by: Galvanize Therapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
    • California
      • Rancho Mirage, California, United States, 92270
    • Florida
      • Naples, Florida, United States, 34102
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York Presbyterian Langone Health
        • Contact:
        • Principal Investigator:
          • William Moore, MD
        • Sub-Investigator:
          • Daniel Sterman, MD
        • Sub-Investigator:
          • Jamie Bessich, MD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Hospital
        • Principal Investigator:
          • Kamran Mahmood, MD
        • Contact:
        • Sub-Investigator:
          • Joseph Mammarappallil
        • Sub-Investigator:
          • Coral Giovaccini, MD
        • Sub-Investigator:
          • Michael Harowicz, MD
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute for Medical Research (LIMR)
        • Principal Investigator:
          • Patrick Ross, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Thomas Meyer, MD
        • Sub-Investigator:
          • Ricky Tong, MD, PhD
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health
        • Principal Investigator:
          • Abhijit Raval, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Muhanned Abu-Hijleh, MD
        • Sub-Investigator:
          • Inderpal Sarkaria, MD
        • Contact:
        • Sub-Investigator:
          • Takashi Eguchi, MD
        • Sub-Investigator:
          • Audra Schwalk, MD
        • Sub-Investigator:
          • Aitua Salami, MD
      • Tyler, Texas, United States, 75708
        • Recruiting
        • University of Texas-Tyler
        • Contact:
        • Principal Investigator:
          • George Gass, MD
        • Sub-Investigator:
          • Debbie Fielder, MD
        • Sub-Investigator:
          • Christopher Herrick, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Saiesh Vopparu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aliya PEF ablation
Patients will undergo PEF ablation per institutional standard of care
Device: PEF ablation
Pulsed Electric Field (PEF) Ablation per institutional standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia Type Usage for PEF Procedure
Time Frame: PEF procedure
Anesthesia type usage
PEF procedure
PEF Target Location
Time Frame: PEF procedure
PEF procedural target location
PEF procedure
PEF Target Size
Time Frame: PEF procedure
PEF target size (cm)
PEF procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SAEs
Time Frame: within 30 days of PEF energy delivery
Incidence of SAEs (Registry device and/or procedure related)
within 30 days of PEF energy delivery
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)
within 30 days of PEF energy delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galvanize Therapeutics, Inc.

Investigators

  • Study Chair: William Krimsky, MD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSP-00017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan of data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Soft Tissue Lesion

Clinical Trials on PEF ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe