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Pulsed Field Ablation for the Treatment of Malignant Lung Tumors
Sponsor: Shanghai Chest Hospital
Summary
This prospective, single-center, single-arm exploratory study will evaluate the safety and effectiveness of a pulsed field ablation system and a single-use pulsed field ablation catheter for the treatment of malignant lung tumors. Pulsed field ablation uses short electrical pulses to ablate targeted tumor tissue. The study plans to enroll 15 adult participants at Shanghai Chest Hospital. Each participant will undergo bronchoscopic pulsed field ablation and will be followed for 6 months after the procedure. The main outcome is the proportion of treated lesions showing complete ablation at 6 months. Technical success, tumor control, survival, quality of life, and adverse events will also be evaluated.
Official title: An Exploratory Clinical Trial to Evaluate a Pulsed Field Ablation System and a Single-Use Pulsed Field Ablation Catheter for the Treatment of Malignant Lung Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-10
Completion Date
2028-10
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter
The pulsed field ablation system is used together with a single-use pulsed field ablation catheter. The catheter is advanced through the bronchial route to the target lung lesion, and the system delivers pulsed electrical energy to ablate the targeted tumor tissue. Device placement and ablation are performed according to the study protocol. Supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit if clinically appropriate.
Locations (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China