Galvanize Prospective/Retrospective Pulsed Electric Field... | NCT05851430

Studies
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

NCT05851430

Sponsor

Galvanize Therapeutics, Inc.

Status

Recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Soft Tissue Lesion

Interventions

PEF ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2025Actual

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

May 8, 2023

First Posted Date

May 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aliya PEF ablation		Patients will undergo PEF ablation per institutional standard of care	Device: PEF ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEF ablation	Device	Pulsed Electric Field (PEF) Ablation per institutional standard of care	Aliya PEF ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anesthesia Type Usage for PEF Procedure	Anesthesia type usage	PEF procedure
PEF Target Location	PEF procedural target location	PEF procedure
PEF Target Size	PEF target size (cm)	PEF procedure

Secondary Outcomes

Measure	Description	Time Frame
Incidence of SAEs	Incidence of SAEs (Registry device and/or procedure related)	within 30 days of PEF energy delivery
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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
Signed informed consent is obtained, if required by IRB

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Partha Seshaiah, PhD	Contact	650-268-4252		pseshaiah@galvanizetx.com

Overall Officials

Name	Affiliation	Role
William Krimsky, MD	Chief Medical Officer	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banner Health	Recruiting	Gilbert	Arizona	85234	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan of data sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided