Recruiting

Observational Study

Sponsor:

Galvanize Therapeutics, Inc.

Code:

NCT05851430

Conditions

Soft Tissue Lesion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PEF ablation

Study Details

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.

Conditions

Soft Tissue Lesion

Study ID

NCT05851430

Start date

Jun 23, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Aliya PEF ablation

Patients will undergo PEF ablation per institutional standard of care

Interventions

PEF ablation

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

Primary outcome measure

  • Anesthesia Type Usage for PEF Procedure [ Time Frame: PEF procedure ]
  • PEF Target Location [ Time Frame: PEF procedure ]
  • PEF Target Size [ Time Frame: PEF procedure ]

Central Contacts and Locations

Central contacts

Locations

Banner Health

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Archan Shaw, MD

Eisenhower Medical Center

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Principal Investigator:

Justin Thomas, MD

NCH Baker

Recruiting

Naples, Florida, United States, 34102

Contacts

Yanna Prishchepa, RN

yanna.prishchepa@nchmd.org

Principal Investigator:

David Lindner, MD

New York Presbyterian Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

William Moore, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Kamran Mahmood, MD

Lankenau Institute for Medical Research (LIMR)

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Jessica Burrell, BA, BS, CCRP

BurrellJe@mlhs.org

Principal Investigator:

Patrick Ross, MD, PhD

AnMed Health

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Principal Investigator:

Abhijit Raval, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Muhanned Abu-Hijleh, MD

Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Ali Abedi, MD

University of Texas-Tyler

Recruiting

Tyler, Texas, United States, 75708

Contacts

Principal Investigator:

George Gass, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Saiesh Vopparu, MD

More Information

Sponsor

Galvanize Therapeutics, Inc.

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • Pulsed Electric Fields

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Galvanize Therapeutics, Inc. on 2026-07-02.