Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules
NCT07638228 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-06-10
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
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Sir Run Run Shaw Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2026-10-20
- Completion
- 2026-12-31
Countries
- China
Study Locations
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