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NCT06739031Recruiting

Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors

A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are: * Safety of PEF treatment of early-stage unreseectable NSCLC patients. * Locoregional control of ablated lesions. * Survival and quality of life assessment of early-stage unreseectable NSCLC patients.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
126 (estimated)
First submitted
9 Dec 2024
Start date
25 Dec 2024
Primary completion date
25 Dec 2026
Lead sponsor
Energenx Medical LTD.
Diseases
Lung cancer
NCT number
NCT06739031

What you commit to

  • Study type: Interventional
  • Planned participants: 126
  • From 25 Dec 2024 to the primary completion date, 25 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has a history of severe allergic reactions;

Lab values

  • Has contraindications to bronchoscopy or refuses bronchoscopy;
    • 5\. Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR\>1.5 or APTT\>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets \<50×10\^9/L; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.

Other

  • The subject cannot tolerate or refuses general anesthesia;

Who the study is looking for

  • 1\. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.