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Not Yet Recruiting NCT07799194

For Patients With Early-Stage Non-Small Cell Lung Cancer or Lung Oligo-metastatic Tumor, Applying Pulsed Electric Field Energy Through Percutaneous Approach To Ablate the Tumor and Evaluate the Safety and Initial Efficacy.

Conditions: Lung Cancer (NSCLC)

Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Energenx Medical LTD.

Location: The First Affiliated Hospital of Guagnzhou Medical University Guangzhou Guangdong

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

Eligibility Criteria

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 \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.

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Source: ClinicalTrials.gov (NCT07799194). StuddyBuddy aggregates publicly available trial information.