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

NCT07638228 | Active Not Recruiting

• 1 other identifier: SirRRSH2025- 0602
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Pulmonary Nodules; Lung Cancer

Keywords

malignant pulmonary nodules; Lung Cancer; effectiveness and safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary Efficacy Endpoints:

  6 months

• Secondary Outcome Measure

  6 month

• Secondary Outcome Measure

  6 month

• Secondary Outcome Measure

  6 month

Study Arms (1)

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

EXPERIMENTAL

Device: wideband electric pulse tumor ablation system treatment

Interventions

wideband electric pulse tumor ablation system treatment DEVICE

Anesthesia management: Intravenous anesthesia Surgical procedure: 1. Intraoperative monitoring of blood pressure, electrocardiogram (ECG), and oxygen saturation. 2. Insertion of the ablation catheter/needle into the nodule position. 3. Application of IRE to perform ablation of the pulmonary lesion. Guidance approach: 1. The subject will first undergo interventional bronchoscopy to reach the target lesion via the bronchial pathway. 2. Intraoperative percutaneous needle placement under CT guidance.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:
• Stage IA primary non-small cell lung cancer; or
• Intrapulmonary metastatic tumors with the primary lesion well controlled.
• Solitary lesion size ≤ 2 cm, and total number of lesions ≤ 3.
• ECOG performance status score ≤ 2.
• Patients who are ineligible for surgery/radiotherapy, or who refuse surgery/radiotherapy, or who voluntarily participate.

You may not qualify if:

• A patient will be excluded from participation in this clinical trial if any of the following conditions apply:
• 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.
• Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
• Infectious or radiation-induced inflammation around the lesion, poorly controlled skin infection at the puncture site, systemic infection, or fever \> 38.5°C.
• 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.
• Poorly controlled malignant pleural effusion.
• Distant metastasis of lung cancer.
• Concurrent other malignancies with extensive metastasis, and expected survival \< 6 months.
• Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.
• The target lesion has received prior local treatments (e.g., radiotherapy, ablation) within 3 months before enrollment.
• Participation in any drug and/or medical device clinical trial within 1 month before enrollment.
• Pregnancy, lactation, or planned pregnancy within one year.
• Any other condition that the investigator considers inappropriate for enrollment.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 10, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)