[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654435":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":36,"armGroups":52,"interventions":59,"overallOfficials":36,"centralContacts":65,"locations":74,"responsibleParty":94,"collaborators":36,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":36,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":36,"studyType":109,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":116,"whyStopped":36,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Energenx Medical LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"The clinical safety of the device and\u002For 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\u002For procedure during the ablation procedure and thereafter 12 months follow-Up","Through 12 months",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"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catheter is deployed to the target lesion and pulsed electrical field energy is delivered and then the catheter is withdrawn out from lung","Once the procedure is completed.",{"measure":19,"description":20,"timeFrame":21},"The technical success rate of the PEF ablation","The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.","At 24-hour post the procedure",{"measure":23,"description":24,"timeFrame":25},"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\n\n① 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\u002For no metabolic activity on PET\u002FCT; ⑤ Atelectasis, with the lesion within the atelectasis showing no contrast enhancement on CT and\u002For no metabolic activity on PET\u002FCT.\n\nThe baseline is defined as CT image of 4-6 weeks post the ablation.","At 6-month and 12-month",{"measure":27,"description":28,"timeFrame":29},"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.","At 12 months",{"measure":31,"description":32,"timeFrame":29},"Overall Survival (OS) through 12 months.","The proportion of surviving subjects at 12 months after completion of PEF ablation therapy in those evaluative subjects.",[34,38,41],{"measure":35,"description":36,"timeFrame":37},"Proportion of patients requiring initiation of any other anti-tumor interventions since PEF ablation up to 12 months.",null,"At 12-month",{"measure":39,"description":40,"timeFrame":12},"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\u002FFVC in percentage, Total Lung Capacity (TLC) in liter, Residual Volume (RV) in liter, Ratio of RV\u002FTLC in percentage and Diffusing Capacity of the Lungs for Carbon Monoxide(DLCO) in ml\u002FmmHg\u002Fmin and the percentages of all of the measures compared with the predicted value accordingly at 6-month and 12-month post procedure.",{"measure":42,"description":43,"timeFrame":44},"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.\n\nEORTC QLQ-C30(version 3.0) include global health status, functional scale and symptom scales\u002Fitems. 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.\n\nEORTC 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.","through 12 months",{"allocation":46,"interventionModel":47,"interventionModelDescription":36,"primaryPurpose":48,"observationalModel":36,"timePerspective":36,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":36,"whoMasked":36},"NONE","Safety, technical feasibility including procedure operation success and tumor ablation technical success be evaluated.\n\nThe primary efficacy endpoint is the complete ablation rate of the ablated lesions at month 6.\n\nOther 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.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Single arm","OTHER","A non-thermal energy named pulsed electric field(PEF)",[58],"Device: Pulsed Electric Field Ablation",[60],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":36},"DEVICE","Pulsed Electric Field Ablation","Application of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.",[54],[66,71],{"name":67,"role":68,"phone":69,"phoneExt":36,"email":70},"Shaoyu Yang, Doctor","CONTACT","+86-18910093103","Shaoyu.yang@energenxmedical.com",{"name":72,"role":68,"phone":36,"phoneExt":36,"email":73},"Xiao Xu, Head of Administrator","Sara.Xu@energenxmedical.com",[75],{"facility":76,"status":36,"city":77,"state":78,"zip":36,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The First Affiliated Hospital of Guagnzhou Medical University","Guangzhou","Guangdong","China","CN",{"type":82,"coordinates":83},"Point",[84,85],113.25,23.11667,{"lat":85,"lon":84},[88,91],{"name":89,"role":68,"phone":36,"phoneExt":36,"email":90},"Chengzhi Zhou, Professor","doctorzcz@163.com",{"name":92,"role":68,"phone":36,"phoneExt":36,"email":93},"Xiaohong Xie, Associated Director","gyxxh@126.com",{"type":95,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100654435","a-clinical-study-to-evaluate-the-performances-of-a-pulsed-electric-field-ablation-through-percutaneous-approach-for-patients-with-early-stage-lung-cancer-or-lung-oligometastatic-tumor-100654435",false,"NCT07799194","Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study","A Clinical Study To Evaluate Safety, Technical Feasibility, and Preliminary Efficacy of A Pulsed Electrical Field Ablation Through Percutaneous Approach For Treatment of Patient With Primary Early-Stage Non-Small Cell Lung Cancer or Lung Oligo-metastatic Tumor Who Are Unresectable or Refusal to Surgery\u002FRadiotherapy.","Inclusion Criteria:\n\n1. Age ≥18 years but ≤ 79 years, male or female\n2. 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)\n3. 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 \\\u003C5), the maximum diameter of the lesion(s) is ≤3cm.\n4. ECOG score ≤ 2;\n5. Expected survival ≥ 12 months;\n6. Clinical assessment as unsuitable for surgical resection or refusing surgery and radiotherapy.\n7. Assessed by an anesthesiologist as suitable for general anesthesia;\n8. Agree to receive ablation therapy and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.\n2. Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.\n\n   (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).\n3. The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.\n4. With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure\u002Ffollow-up (such as contrast-enhanced CT scan).\n5. Anemia (Hemoglobin (HGB) \\\u003C 9 g\u002FdL), dehydration, and severe metabolic disorders that cannot be improved or well managed in the short term.\n6. Coagulation abnormalities (INR \\>1.5 or APTT \\>1.5 ULN), or platelet count below 90 x 10\\^9\u002FL.\n7. Uncontrolled lung or systemic infection. Or uncontrolled skin infection at the puncture site or fever \\> 38.5°C.\n8. Currently using anticoagulant therapy and\u002For 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.\n9. Receiving high-dose immunosuppressive drugs (prednisone exceeding 10mg\u002Fday or equivalent). If discontinued for more than 4 weeks, it is acceptable.\n10. 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.\n11. Malignant pleural effusion on the treatment side of lung.\n12. Severe uncontrolled hypertension, diabetes, severe abnormal liver or kidney function, or heart failure that investigator assessed as unsuitable for enrollment.\n13. Acute cardio-cerebrovascular events within 3 months, such as acute hemorrhagic or ischemic stroke, acute coronary syndrome, acute myocardial infarction.\n14. Psychiatric disease that not well controlled.\n15. 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 \\\u003C 45 beats\u002Fmin, or sinus tachycardia \\> 120 beats\u002Fmin.\n16. Implanted electronic device in the body (such as pacemaker, implantable cardioverter defibrillator, or neurostimulator).\n\n    (it is acceptable If the implanted electronic device is allowed to be turned off during the procedure)\n17. There is metal implants near the lesion to be ablated lesion (distance \\\u003C 2-3cm) in the lung.\n18. Patient is currently participating in another clinical trial.\n19. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.\n20. Other situations judged by investigator as unsuitable for enrollment.","ALL","18 Years","79 Years",{"count":107,"type":108},10,"ESTIMATED","INTERVENTIONAL",[46],"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\u002FRadiotherapy.\n\nThe main questions the study aims to answer are:\n\nThe safety and technical feasibility of the PEF ablation. The preliminary efficacy of the PEF ablation for target lesion in lung\n\nPatients who meet the inclusion\u002Fexclusion 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.\n\nTarget 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\u002Fradiotherapy",[113],"Lung Cancer (NSCLC)",[115,62],"Lung Caner(NSCLC)","NOT_YET_RECRUITING","2026-09-07",{"date":119,"type":120},"2026-09-10","ACTUAL",{"date":122,"type":108},"2026-09",{"date":124,"type":108},"2028-06",{"name":5,"class":6},1]