Actively Recruiting
Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study
Led by Galvanize Therapeutics, Inc. · Updated on 2026-03-23
25
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, single-arm, non-randomized, single-center, open-label, treat and resect study following patients through surgical resection. The study is designed to evaluate the safety and feasibility of the Aliya EX System for the ablation of pulmonary lesions using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed pulmonary malignant lesion(s) ≥1.5 cm to ≤4 cm whom are surgical candidates and have not received treatment for the index tumor in the last two years.
CONDITIONS
Official Title
Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of at least one lung lesion measuring 1.5 cm to 4 cm diameter by CT deemed suitable for PEF ablation
- High probability of malignancy as determined by the investigator
- Candidate for definitive lung tissue resection per institutional standard of care
- Able to adhere to and undergo PEF and surgical procedures
- Able to tolerate general anesthesia
- 18 years of age or older
- Provided informed consent
You will not qualify if you...
- Requires neoadjuvant therapy for the disease intended for surgical resection
- Receiving concurrent cancer treatment such as radiation, chemotherapy, targeted therapy, immunotherapy, or other focal therapy
- Received effective treatment for the target lesion within the last two years prior to consent
- Prior pneumonectomy
- Serious medical condition that could compromise safety or confound response to PEF ablation
- Receiving oral corticosteroid therapy over 10 mg/day or equivalent within 30 days of the PEF procedure
- Currently enrolled in another interventional clinical trial
- Physical or psychological condition impairing study participation or safety
- Women who are pregnant, nursing, or planning pregnancy during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
M
Maria Plentl, MSN
CONTACT
P
Partha Seshaiah, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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