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Recruiting
NCT05851430
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Conditions: Soft Tissue Lesion
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 1000
Sponsor: Galvanize Therapeutics, Inc.
Location: Banner Health Gilbert Arizona
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05851430). StuddyBuddy aggregates publicly available trial information.
