RECRUITING

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Description

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

Study Details

Study overview

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.

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Condition
Soft Tissue Lesion
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Hospital, Durham, North Carolina, United States, 27705

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Galvanize Therapeutics, Inc.,

William Krimsky, MD, STUDY_CHAIR, Chief Medical Officer

Study Record Dates

2028-12-31