Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules

Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules: A First-in-Human (FIM) Trial

To evaluate the safety and efficacy of the wideband electric pulse tumor ablation system, for the treatment of malignant pulmonary nodules.

Subjects will first undergo interventional bronchoscopy to access the target lesion via the bronchial pathway. During the procedure, the physician will perform percutaneous needle placement under CT guidance and use IRE (irreversible electroporation) to ablate the pulmonary lesion.

A pulmonary nodule (PN) refers to a round or irregular lesion within the lung with a diameter ≤3 cm. Radiologically, it appears as a focus of increased density, which may be solitary or multiple, with well-defined or ill-defined margins. The malignant probability of pulmonary nodules varies according to their density, and based on nodule density, they are classified into three types: solid nodules, part-solid nodules, and ground-glass nodules . Currently, lung cancer is the most common and deadliest cancer worldwide, and is also one of the most prevalent malignant tumors in China. Malignant pulmonary nodules are considered an early manifestation of lung cancer; therefore, early detection, early diagnosis, and early treatment are key to improving patient survival.

Current clinical treatment options for pulmonary nodules include surgical resection and ablation techniques, such as radiofrequency ablation, microwave ablation, and cryoablation. However, for pulmonary nodules located in special sites, hot or cold ablation may easily damage the pleura, leading to bronchopleural fistula, and often results in incomplete ablation due to the heat sink effect.

Irreversible electroporation (IRE) employs a mechanism and technical application features completely different from other physical ablation methods. This technique delivers high-voltage electrical pulses via electrode needles to create a high-electric-field ablation zone. Within this zone, numerous irreversible nanoscale pores are formed in the cell membrane, disrupting the intra- and extracellular environment balance and inducing apoptosis, thereby permanently destroying tissue cells. During IRE ablation, only the lipid bilayer of the cell membrane within the ablated area is disrupted, while critical structures such as blood vessels are not severely damaged. Owing to this unique ablation characteristic, IRE offers irreplaceable advantages in the treatment of various diseases, including short treatment time, applicability to more complex conditions, preservation of vital structures within the treatment zone, complete ablation, and well-defined ablation margins.

This clinical trial aims to evaluate the safety and efficacy of the wideband electric pulse tumor ablation system (manufactured by Hangzhou Win-Once Medical Technology Co., Ltd.) in treating malignant pulmonary nodules, providing reference data for the subsequent formal trial.

Inclusion Criteria:

1. Age ≥ 18 years.

2. Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:

   1. Stage IA primary non-small cell lung cancer; or
   2. Intrapulmonary metastatic tumors with the primary lesion well controlled.

3. Solitary lesion size ≤ 2 cm, and total number of lesions ≤ 3.

4. ECOG performance status score ≤ 2.

Patients who are ineligible for surgery/radiotherapy, or who refuse surgery/radiotherapy, or who voluntarily participate.

Exclusion Criteria:

A patient will be excluded from participation in this clinical trial if any of the following conditions apply:

1. Severe bleeding tendency, platelet count < 50×10⁹/L, or coagulation dysfunction (prothrombin time > 18 s, prothrombin activity < 40%) that cannot be corrected in the short term.
2. Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
3. Infectious or radiation-induced inflammation around the lesion, poorly controlled skin infection at the puncture site, systemic infection, or fever > 38.5°C.
4. Severe dysfunction of the liver, kidney, heart, lung, or brain; severe anemia, dehydration, or serious nutritional/metabolic disorders that cannot be corrected or improved in the short term.
5. Poorly controlled malignant pleural effusion.
6. Distant metastasis of lung cancer.
7. Concurrent other malignancies with extensive metastasis, and expected survival < 6 months.
8. Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.
9. The target lesion has received prior local treatments (e.g., radiotherapy, ablation) within 3 months before enrollment.
10. Participation in any drug and/or medical device clinical trial within 1 month before enrollment.
11. Pregnancy, lactation, or planned pregnancy within one year.
12. Any other condition that the investigator considers inappropriate for enrollment.