Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-23

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes

NCT04884425

Type 2 Diabetes

UNKNOWN NA

Effect of Pulsed Signal Therapy in Patella Chondromalacia

NCT02012413

Patella Chondromalacia

COMPLETED NA

P.E.M.F. Therapy of Chronic Wounds

NCT05493943

Chronic Wounds

NOT_YET_RECRUITING NA

Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.

NCT02145962

Neuropathic Diabetic Ulcer - Foot

COMPLETED NA

Change in Skin Elasticity With RF and PEMF

NCT03002194

Skin Abnormalities

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aliya PEF ablation

Patients will undergo PEF ablation per institutional standard of care

PEF ablation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PEF ablation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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