RECRUITING

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Quick Facts

Study Start:2025-06-23
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05851430

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
  2. 2. Subject is expected to be available for follow-up per the enrolling physician's standard care practices
  3. 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. 4. Signed informed consent is obtained, if required by IRB
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Partha Seshaiah, PhD
CONTACT
650-268-4252
pseshaiah@galvanizetx.com

Principal Investigator

William Krimsky, MD
STUDY_CHAIR
Chief Medical Officer

Study Locations (Sites)

Duke University Hospital
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Galvanize Therapeutics, Inc.

  • William Krimsky, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2025-06-23
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-06-23
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Pulsed Electric Fields

Additional Relevant MeSH Terms

  • Soft Tissue Lesion