NCT05851430

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jun 2025Dec 2028

First Submitted

Initial submission to the registry

April 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 28, 2023

Last Update Submit

April 22, 2026

Conditions

Keywords

Pulsed Electric Fields

Outcome Measures

Primary Outcomes (3)

  • Anesthesia Type Usage for PEF Procedure

    Anesthesia type usage

    PEF procedure

  • PEF Target Location

    PEF procedural target location

    PEF procedure

  • PEF Target Size

    PEF target size (cm)

    PEF procedure

Secondary Outcomes (2)

  • Incidence of SAEs

    within 30 days of PEF energy delivery

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

    within 30 days of PEF energy delivery

Study Arms (1)

Aliya PEF ablation

Patients will undergo PEF ablation per institutional standard of care

Device: PEF ablation

Interventions

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

Aliya PEF ablation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Banner Health

Gilbert, Arizona, 85234, United States

RECRUITING

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

RECRUITING

NCH Baker

Naples, Florida, 34102, United States

RECRUITING

New York Presbyterian Langone Health

New York, New York, 10016, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27705, United States

RECRUITING

Lankenau Institute for Medical Research (LIMR)

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

AnMed Health

Anderson, South Carolina, 29621, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas-Tyler

Tyler, Texas, 75708, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Study Officials

  • William Krimsky, MD

    Chief Medical Officer

    STUDY CHAIR

Central Study Contacts

Partha Seshaiah, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 9, 2023

Study Start

June 23, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No plan of data sharing

Locations