Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Soft Tissue Lesion Clinical Trial

— PROPEL  

Official title:

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05851430
• Other study ID #: CSP-00017
• Status: Terminated
• Start date: June 1, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: August 2023
• Source: Galvanize Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is at least 18 years of age

2. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology

3. Subject is expected to be available for follow-up per the enrolling physician's standard care practices

4. Signed informed consent is obtained, if required by IRB Exclusion Criteria: None

Related Conditions & MeSH terms

• Soft Tissue Lesion

Intervention

Device:
• PEF ablation
Pulsed Electric Field (PEF) Ablation per institutional standard of care

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Dayton VA Medical Center	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Galvanize Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthesia Type Usage for PEF Procedure	Anesthesia type usage	PEF procedure
Primary	PEF Target Location	PEF procedural target location	PEF procedure
Primary	PEF Target Size	PEF target size (cm)	PEF procedure
Secondary	Incidence of SAEs	Incidence of SAEs (Registry device and/or procedure related)	within 30 days of PEF energy delivery
Secondary	Unanticipated [not listed in the Instructions for Use (IFU)] adverse events	Unanticipated [not listed in the Instructions for Use (IFU)] adverse events (device-related)	within 30 days of PEF energy delivery