Soft Tissue LesionPROPELNCT05851430
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
An observational study of Soft Tissue Lesion, run by Galvanize Therapeutics, Inc. at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Soft Tissue Lesion
- What is being tested?
- PEF ablation
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Jun 2025to 31 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
AnMed Health
Anderson, South Carolina, 29621
Andrea Franks, Andrea.Franks@anmed.org
Abhijit Raval, MD
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Rhoda Annoh Gordon, rhoda.annohgordon@utsouthwestern.edu
Muhanned Abu-Hijleh, MD
- Recruiting
Duke University Hospital
Durham, North Carolina, 27705
Jessica Shier, jessica.shier@duke.edu
Kamran Mahmood, MD
- Recruiting
Banner Health
Gilbert, Arizona, 85234
Robert Flynn, Robert.Flynn@bannerhealth.com
Archan Shaw, MD
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Misa Shaw, Misa.Shaw1@wvumedicine.org
Saiesh Vopparu, MD
- Recruiting
NCH Baker
Naples, Florida, 34102
Yanna Prishchepa, RN, yanna.prishchepa@nchmd.org
David Lindner, MD
- Recruiting
New York Presbyterian Langone Health
New York, New York, 10016
Priya Bhattacharji, priya.bhattacharji@nyulangone.org
William Moore, MD
- Recruiting
Eisenhower Medical Center
Rancho Mirage, California, 92270
Noor Alomar, nalomar@eisenhowerhealth.org
Justin Thomas, MD
- Recruiting
Methodist Hospital
San Antonio, Texas, 78229
Stephanie Lambert, stephanie.lambert@hcahealthcare.com
Ali Abedi, MD
- Recruiting
University of Texas-Tyler
Tyler, Texas, 75708
Anne Ford, Anne.Ford@uttyler.edu
George Gass, MD
- Recruiting
Lankenau Institute for Medical Research (LIMR)
Wynnewood, Pennsylvania, 19096
Jessica Burrell, BA, BS, CCRP, BurrellJe@mlhs.org
Patrick Ross, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Soft Tissue Lesion
- Being tested
- PEF ablation
- Keywords
- Pulsed Electric Fields
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF ablationDevice
Pulsed Electric Field (PEF) Ablation per institutional standard of care
| Study group | Role | What they receive |
|---|---|---|
| Aliya PEF ablation | Patients will undergo PEF ablation per institutional standard of care Receives: Device: PEF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Type Usage for PEF Procedure
Anesthesia type usage
Measured: PEF procedure
PEF Target Location
PEF procedural target location
Measured: PEF procedure
PEF Target Size
PEF target size (cm)
Measured: PEF procedure
Secondary outcomes (2)
Incidence of SAEs
Incidence of SAEs (Registry device and/or procedure related)
Measured: within 30 days of PEF energy delivery
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events (device-related)
Measured: within 30 days of PEF energy delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start23 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Galvanize Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Krimsky, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851430
- Sponsor's protocol ID
- CSP-00017
- Acronym
- PROPEL
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan of data sharing
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
- ClinicalTrials.gov ID
- NCT05851430
- Acronym / sponsor ID
- PROPEL / CSP-00017
- Conditions
- Soft Tissue Lesion
- Keywords
- Pulsed Electric Fields
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Galvanize Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliya PEF ablation | – | Device: PEF ablationPatients will undergo PEF ablation per institutional standard of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF ablationPulsed Electric Field (PEF) Ablation per institutional standard of care | Device | Aliya PEF ablation |
Primary outcome
Anesthesia Type Usage for PEF Procedure
Time frame: PEF procedure
Anesthesia type usage
PEF Target Location
Time frame: PEF procedure
PEF procedural target location
PEF Target Size
Time frame: PEF procedure
PEF target size (cm)
2 secondary outcomes
Incidence of SAEs
Time frame: within 30 days of PEF energy delivery
Unanticipated [not listed in the Instructions for Use (IFU)] adverse events
Time frame: within 30 days of PEF energy delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. No plan of data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Krimsky, MD study chair
Chief Medical Officer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Lesion, run by Galvanize Therapeutics, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Partha Seshaiah, PhD (650-268-4252, pseshaiah@galvanizetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Type Usage for PEF Procedure (time frame: PEF procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.