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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05851430
Other study ID # CSP-00017
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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