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

March 17, 2026 updated by: Galvanize Therapeutics, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Principal Investigator:
          • Calvin Ng, MD
        • Sub-Investigator:
          • Rainbow Lau, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From the PEF procedure through surgical resection (approximately 30 days later)
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
Time Frame: Intra-procedural
The frequency with which the clinician can access the target lesion and deliver PEF energy
Intra-procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galvanize Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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