PROPEL: Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Sponsor

Galvanize Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05851430

Collaborator

(none)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Lesion	Device: PEF ablation

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Aliya PEF ablation Patients will undergo PEF ablation per institutional standard of care	Device: PEF ablation Pulsed Electric Field (PEF) Ablation per institutional standard of care

Arm

Intervention/Treatment

Aliya PEF ablation

Patients will undergo PEF ablation per institutional standard of care

Device: PEF ablation

Pulsed Electric Field (PEF) Ablation per institutional standard of care

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is at least 18 years of age
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
Signed informed consent is obtained, if required by IRB

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Galvanize Therapeutics, Inc.

Investigators

Study Chair: William Krimsky, MD, Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Galvanize Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05851430

Other Study ID Numbers:

CSP-00017

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Galvanize Therapeutics, Inc.

Pulsed Electric Fields

Study Results

No Results Posted as of May 9, 2023