Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Purpose
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.
Condition
- Soft Tissue Lesion
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Aliya PEF ablation | Patients will undergo PEF ablation per institutional standard of care |
|
Recruiting Locations
Rancho Mirage, California 92270
New York, New York 10016
Wynnewood, Pennsylvania 19096
Dallas, Texas 75390
San Antonio, Texas 78229
Morgantown, West Virginia 26506
More Details
- Status
- Recruiting
- Sponsor
- Galvanize Therapeutics, Inc.
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.