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Not yet recruitingNCT07799194Updated Sep 10, 2026

Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study

An interventional study of Pulsed Electric Field Ablation in Lung Cancer (NSCLC), sponsored by Energenx Medical LTD.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Energenx Medical LTD. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 79 Years
Sex
All
01

Study summary

The goal of this observational study is to evaluate the performances of a percutaneous Pulsed Electrical Field (PEF) ablation to treat patients with primary early-stage lung cancer (NSCLC) or lung oligometastatic Tumors who are unresectable or refusal surgery/Radiotherapy.

The main questions the study aims to answer are:

The safety and technical feasibility of the PEF ablation. The preliminary efficacy of the PEF ablation for target lesion in lung

Patients who meet the inclusion/exclusion criteria will be given percutaneous PEF ablation to the target lesions under general anesthesia. Then follow-up to 12 months to monitor any progression by about 3 months interval.

Target Subject： Patients with early-stage primary non-small cell lung cancer(NSCLC) or pulmonary oligometastatic tumors who are not surgical resectable or unsuitable for surgery/radiotherapy

Read the detailed description

Safety, technical feasibility including procedure operation success and tumor ablation technical success be evaluated.

The primary efficacy endpoint is the complete ablation rate of the ablated lesions at month 6.

Other efficacy endpoints are local tumor progression-Free Survival(PFS), Overall Survival (OS) and proportion of patients requiring initiation of other anti-tumor interventions through 12 months. Pulmonary function and quality of life (EORTC QLQ-C30, EORTC QLQ-LC13) will be assessed as well.

02

Conditions studied

  • Lung Cancer (NSCLC)

Keywords

  • Lung Caner(NSCLC)
  • Pulsed Electric Field Ablation
03

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years but ≤ 79 years, male or female
  2. Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
  3. For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides \<5), the maximum diameter of the lesion(s) is ≤3cm.
  4. ECOG score ≤ 2;
  5. Expected survival ≥ 12 months;
  6. Clinical assessment as unsuitable for surgical resection or refusing surgery and radiotherapy.
  7. Assessed by an anesthesiologist as suitable for general anesthesia;
  8. Agree to receive ablation therapy and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.

  2. Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.

    (For pulmonary oligometastatic tumors with primary cancer controlled already, if systemic anti-tumor therapy still needs to be continued, it is acceptable. For primary NSCLC patients, according to guideline recommendations, no concurrent systemic anti-tumor therapy is indicated).

  3. The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
  4. With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
  5. Anemia (Hemoglobin (HGB) \< 9 g/dL), dehydration, and severe metabolic disorders that cannot be improved or well managed in the short term.
  6. Coagulation abnormalities (INR >1.5 or APTT >1.5 ULN), or platelet count below 90 x 10\^9/L.
  7. Uncontrolled lung or systemic infection. Or uncontrolled skin infection at the puncture site or fever > 38.5°C.
  8. Currently using anticoagulant therapy and/or antiplatelet drugs (such as warfarin, dabigatran, rivaroxaban, and other new oral anticoagulants) and have not been discontinued for more than 5 to 7 days prior to ablation therapy.
  9. Receiving high-dose immunosuppressive drugs (prednisone exceeding 10mg/day or equivalent). If discontinued for more than 4 weeks, it is acceptable.
  10. Subject has comorbidity of severe other lung diseases (including interstitial pneumonia, pulmonary fibrosis, severe emphysema or atelectasis) and unsuitable for enrollment with the judgement of the investigator.
  11. Malignant pleural effusion on the treatment side of lung.
  12. Severe uncontrolled hypertension, diabetes, severe abnormal liver or kidney function, or heart failure that investigator assessed as unsuitable for enrollment.
  13. Acute cardio-cerebrovascular events within 3 months, such as acute hemorrhagic or ischemic stroke, acute coronary syndrome, acute myocardial infarction.
  14. Psychiatric disease that not well controlled.
  15. With a history of recurrent tachyarrhythmia past 2 years. (Including rapid atrial arrhythmias, any rapid ventricular arrhythmias); or history of type II second-degree or III degree atrioventricular block or sinus bradycardia with heart rate \< 45 beats/min, or sinus tachycardia > 120 beats/min.

  16. Implanted electronic device in the body (such as pacemaker, implantable cardioverter defibrillator, or neurostimulator).

    (it is acceptable If the implanted electronic device is allowed to be turned off during the procedure)

  17. There is metal implants near the lesion to be ablated lesion (distance \< 2-3cm) in the lung.
  18. Patient is currently participating in another clinical trial.
  19. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
  20. Other situations judged by investigator as unsuitable for enrollment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Single arm

    A non-thermal energy named pulsed electric field(PEF)

    Device: Pulsed Electric Field Ablation

Interventions

  • DevicePulsed Electric Field Ablation

    Application of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.

05

What researchers measure

Primary outcomes

  1. The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.

    Adverse events rate and severe adverse event rate related to the device and/or procedure during the ablation procedure and thereafter 12 months follow-Up

    Time frame: Through 12 months

Secondary outcomes

  1. The success rate of the ablation procedure

    The success rate of the procedure is defined as the proportion of ablation procedures in which the PEF treatment catheter is deployed to the target lesion and pulsed electrical field energy is delivered and then the catheter is withdrawn out from lung

    Time frame: Once the procedure is completed.

  2. The technical success rate of the PEF ablation

    The technical success rate of the PEF ablation that is defined as the proportion of lesions where the CT imaging-assessed ablation zone (Post-ablation Target Zone, PTZ) is larger than the gross tumor region (GTR) at least 5 mm.

    Time frame: At 24-hour post the procedure

  3. Complete ablation rate of the target lesions at 6-month and 12-month post the ablation.

    Complete ablation of the target lesions is defined as to achieve the following criteria on contrast-enhanced CT images ① Lesion disappears; ② Complete cavity formation; ③ Lesion fibrosis, which may be a scar; ④ Lesion shrinks, remains unchanged, or enlarges, but shows no enhancement on contrast-enhanced CT and/or no metabolic activity on PET/CT; ⑤ Atelectasis, with the lesion within the atelectasis showing no contrast enhancement on CT and/or no metabolic activity on PET/CT. The baseline is defined as CT image of 4-6 weeks post the ablation.

    Time frame: At 6-month and 12-month

  4. Proportion of patients with target tumor progression free survival (PFS) at 6-month and 12-month.

    The proportion of subjects without target lesion progression in lung at 6-month and 12-month post the PEF procedure in evaluative subjects.

    Time frame: At 12 months

  5. Overall Survival (OS) through 12 months.

    The proportion of surviving subjects at 12 months after completion of PEF ablation therapy in those evaluative subjects.

    Time frame: At 12 months

Other outcomes

  1. Proportion of patients requiring initiation of any other anti-tumor interventions since PEF ablation up to 12 months.

    Time frame: At 12-month

  2. Pulmonary function measures at 6-month and 12-month

    The pulmonary function measures includes Forced Vital Capacity (FVC) in liter, Forced Expiratory Volume in the first second (FEV1) in liter, Ratio of FEV1/FVC in percentage, Total Lung Capacity (TLC) in liter, Residual Volume (RV) in liter, Ratio of RV/TLC in percentage and Diffusing Capacity of the Lungs for Carbon Monoxide(DLCO) in ml/mmHg/min and the percentages of all of the measures compared with the predicted value accordingly at 6-month and 12-month post procedure.

    Time frame: Through 12 months

  3. Quality of Life assessed at 3-month, 6-month and 12-month.

    EORTC QLQ-C30(European Organisation for Research and Treatment of Cancer Quality of Life, The Core Questionnaire) and EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life, Lung Cancer Questionnaire) be used to assess the quality of life. EORTC QLQ-C30(version 3.0) include global health status, functional scale and symptom scales/items. The range of the score is from zero to 100 points. For functional and global health status, the higher score mean a better conditions. For symptom domain, the higher score reversely indicates worse status. EORTC QLQ-LC13 is designed to assess the quality of life in patient with lung cancer. The range of score is from zero to 100 points. The higher score mean the worse symptoms.

    Time frame: through 12 months

06

Study locations

1 site
  • The First Affiliated Hospital of Guagnzhou Medical University
    Guangzhou, Guangdong, China
07

References and documents

Individual participant data

Plan to share: Undecided — so far it has not be decided.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07799194
Lead sponsor
Energenx Medical LTD.
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Shaoyu Yang, Doctor
Contact
Shaoyu.yang@energenxmedical.com
+86-18910093103
Xiao Xu, Head of Administrator
Contact
Sara.Xu@energenxmedical.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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