Lung CancerTARGETNCT07487064
Galvanize Aliya® EX Pulsed Electric Field (PEF) Treat and Resect Study
A study testing Aliya Pulsed Electric Field (PEF) in people with Lung Cancer, run by Galvanize Therapeutics, Inc. at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Aliya Pulsed Electric Field (PEF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Mar 2026to 28 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Junko Chan, (852) 3505 2629, junkochan@surgery.cuhk.edu.hk
Calvin Ng, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Aliya Pulsed Electric Field (PEF)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliya Pulsed Electric Field (PEF)Device
Pulsed electric field treatment using the Aliya EX System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Single treatment arm-PEF Receives: Device: Aliya Pulsed Electric Field (PEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure related serious adverse event rate
Rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Measured: 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
Measured: Intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start13 Mar 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galvanize Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487064
- Sponsor's protocol ID
- CSP-00021
- Acronym
- TARGET
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Targeted Ablation and Resection Study With Galvanize Aliya® EX Pulsed Electric Field (PEF) Technology
- ClinicalTrials.gov ID
- NCT07487064
- Acronym / sponsor ID
- TARGET / CSP-00021
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Galvanize Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Aliya Pulsed Electric Field (PEF)Single treatment arm-PEF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Aliya Pulsed Electric Field (PEF)Pulsed electric field treatment using the Aliya EX System | Device | Treatment |
Primary outcome
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)
Technical success
Time frame: Intra-procedural
The frequency with which the clinician can access the target lesion and deliver PEF energy
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliya Pulsed Electric Field (PEF) in people with Lung Cancer, run by Galvanize Therapeutics, Inc. at 1 site in Hong Kong.
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 7 inclusion and 9 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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 Maria Plentl, MSN ((650) 268-4252, mplentl@galvanizetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and Procedure related serious adverse event rate (time frame: From the PEF procedure through surgical resection (approximately 30 days later)). The study lists 2 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 23 Mar 2026.