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Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules
Sponsor: Sir Run Run Shaw Hospital
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.
Official title: Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules: A First-in-Human (FIM) Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2025-09-01
Completion Date
2026-12-31
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
wideband electric pulse tumor ablation system treatment
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.
Locations (1)
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China