Soft Tissue Lesion
Conditions
Keywords
Pulsed Electric Fields
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.
Detailed description
This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology. Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up. Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.
Interventions
DEVICEPEF ablation
Pulsed Electric Field (PEF) Ablation per institutional standard of care
Sponsors
Galvanize Therapeutics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Type Usage for PEF Procedure | PEF procedure | Anesthesia type usage |
| PEF Target Location | PEF procedure | PEF procedural target location |
| PEF Target Size | PEF procedure | PEF target size (cm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SAEs | within 30 days of PEF energy delivery | Incidence of SAEs (Registry device and/or procedure related) |
| Unanticipated [not listed in the Instructions for Use (IFU)] adverse events | within 30 days of PEF energy delivery | Unanticipated \[not listed in the Instructions for Use (IFU)\] adverse events (device-related) |
Countries
United States
Contacts
CONTACTPartha Seshaiah, PhD
STUDY_CHAIRWilliam Krimsky, MD
Chief Medical Officer
Outcome results
None listed