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ACTIVE NOT RECRUITING
NCT07638228
NA

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

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

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

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.

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China