Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851430
Status:
TERMINATED
Last Update Posted:
2023-09-06
First Post:
2023-04-28
Brief Title:
Galvanize ProspectiveRetrospective Pulsed Electric Field Device Registry
Sponsor:
Galvanize Therapeutics Inc
Organization:
Galvanize Therapeutics Inc
Study Overview
Official Title:
Galvanize ProspectiveRetrospective Pulsed Electric Field Device Registry
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPEL
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None