Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study (TARGET)

A Targeted Ablation and Resection Study With Galvanize Aliya® EX Pulsed Electric Field (PEF) Technology

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Aliya Pulsed Electric Field (PEF)

Detailed Description

This study is to evaluate the safety and technical success of delivering Aliya® pulsed electric fields (Aliya PEF) for ablation of pulmonary lesions in patients with suspected or confirmed malignancy, prior to planned surgical resection.

Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:

Bronchoscopic approach: Aliya® EX Generator, the INUMI Flex Needle and the Aliya® Electrode.

Percutaneous approach: Aliya® EX Generator, the Aliya® Needle and the Aliya® Electrode.

The study will enroll and treat up to 25 adult patients with suspected or confirmed pulmonary malignant lesion(s) in patients whom are surgical candidates at 1 clinical site.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Plentl, MSN; Phone Number: (650) 268-4252; Email: mplentl@galvanizetx.com
• Study Contact Backup: Name: Partha Seshaiah, PhD; Phone Number: (650) 268-4252; Email: pseshaiah@galvanizetx.com

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Principal Investigator: Calvin Ng, MD
    • Sub-Investigator: Rainbow Lau, MD
    • Contact: Junko Chan; Phone Number: (852) 3505 2629; Email: junkochan@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of at least one lesion in the lung measuring ≥ 1.5 cm and ≤ 4 cm diameter by computed tomography (CT) size estimate deemed suitable for PEF ablation per institutional guidelines.
• High probability of malignancy as determined by the investigator.
• Patient has been deemed a candidate for definitive lung tissue resection per institutional SOC.
• Patient is, in the opinion of the Principal Investigator (PI), able to adhere to and undergo the PEF and surgical procedures.
• Patient is able to tolerate general anesthesia.
• Patient is 18 years of age or older.
• Patient has provided informed consent.

Exclusion Criteria:

• Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
• Patient is receiving concurrent cancer treatment (e.g., external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy).
• Patient has received effective treatment for the target lesion in the last two years prior to the date of consent.
• Patient has undergone prior pneumonectomy.
• Patient has a serious medical condition that, in the Principal Investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to PEF ablation (e.g., major organ dysfunction, active autoimmune disease, immune compromised or receiving immune modulating medication that has resulted in substantial clinical change).
• Patient is receiving oral corticosteroid therapy (>10mg/day or equivalent) within 30 days of the PEF procedure.
• Patient is currently enrolled in another interventional clinical trial.
• Patient has a physical or psychological condition that would impair study participation or jeopardize the safety or welfare of the patient.
• Women of childbearing potential who are pregnant, nursing, or planning to get pregnant during their participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Single treatment arm-PEF	Device: Aliya Pulsed Electric Field (PEF); Pulsed electric field treatment using the Aliya EX System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device and Procedure related serious adverse event rate	Rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)	From the PEF procedure through surgical resection (approximately 30 days later)
Technical success	The frequency with which the clinician can access the target lesion and deliver PEF energy	Intra-procedural

Collaborators and Investigators

• Sponsor: Galvanize Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CSP-00021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No