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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Malignant Pulmonary Nodules
• Intervention / Treatment: Device: wideband electric pulse tumor ablation system treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental Group: Patients treated by wideband electric pulse tumor ablation system

Device: wideband electric pulse tumor ablation system treatment; Anesthesia management: Intravenous anesthesia Surgical procedure: Intraoperative monitoring of blood pressure, electrocardiogram (ECG), and oxygen saturation.; Insertion of the ablation catheter/needle into the nodule position.; Application of IRE to perform ablation of the pulmonary lesion. Guidance approach: The subject will first undergo interventional bronchoscopy to reach the target lesion via the bronchial pathway.; Intraoperative percutaneous needle placement under CT guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of nodule ablation at 1 month after ablation	Success rate of nodule ablation at 1 month after ablation Definition of ablation success:No obvious enhancement in the ablated area on contrast-enhanced CT, indicating complete ablation. The success rate is assessed per nodule, and each nodule is evaluated independently.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoints:	(1) Technical success rate: Defined as the proportion of ablation procedures in which the investigational device is successfully placed in the target lesion, completes ablation, and is successfully withdrawn after treatment, relative to all ablation procedures performed.	6 months
Secondary Outcome Measure	Complete nodule ablation rate at 3 and 6 months post-ablation.	6 month
Secondary Outcome Measure	Nodule recurrence rate at 6 months post-ablation.	6 month
Secondary Outcome Measure	Progression-free survival rate at 6 months post-ablation.	6 month

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; effectiveness and safety; malignant pulmonary nodules
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SirRRSH2025- 0602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No