Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
ConditionSoft Tissue Lesion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorGalvanize Therapeutics, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
PEF ablation
DevicePulsed Electric Field (PEF) Ablation per institutional standard of care
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Aliya PEF ablation1 intervention
Trial outcomes
Primary outcomes
1
Anesthesia Type Usage for PEF Procedure
Anesthesia type usage
Time frame
PEF procedure2
PEF Target Location
PEF procedural target location
Time frame
PEF procedure3
PEF Target Size
PEF target size (cm)
Time frame
PEF procedureSecondary outcomes
1
Incidence of SAEs
Incidence of SAEs (Registry device and/or procedure related)
Time frame
within 30 days of PEF energy delivery2
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events
Unanticipated \[not listed in the Instructions for Use (IFU)\] adverse events (device-related)
Time frame
within 30 days of PEF energy deliverySponsors and contacts
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Source ClinicalTrials.gov