Clinical trial NCT06739031: Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NSCLC
Lead sponsor: Energenx Medical LTD.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria (all requirements must be met at the same time):

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.

Exclusion criteria (if any of the above conditions are met, the patient will be excluded):

1. The subject cannot tolerate or refuses general anesthesia;
2. Has a history of severe allergic reactions;
3. 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.

Primary outcomes:
measure: 6-month complete ablation rate
timeFrame: 6 months
Secondary outcomes:
measure: Technical success rate
timeFrame: immediately after the PEF ablation treatment
measure: 6-month pulmonary progression-free survival rate
timeFrame: 6 months after the first PEF ablation treatment
measure: 12-month complete ablation rate
timeFrame: 12 months after the first PEF ablation treatment
measure: 12-month pulmonary progression-free survival rate
timeFrame: 12 months after the first PEF ablation treatment
measure: 12-month overall survival rate
timeFrame: 12 months after the first PEF ablation treatment
Other outcomes:
measure: Safety of Intervention
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,
Study officials:
References: