NCT07487064

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 13, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Treatment

EXPERIMENTAL

Single treatment arm-PEF

Device: Aliya Pulsed Electric Field (PEF)

Interventions

Aliya Pulsed Electric Field (PEF)DEVICE

Pulsed electric field treatment using the Aliya EX System

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Maria Plentl, MSN

CONTACT

(650) 268-4252mplentl@galvanizetx.com

Partha Seshaiah, PhD

CONTACT

(650) 268-4252pseshaiah@galvanizetx.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

March 13, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)