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NOT YET RECRUITING
NCT07889297
NA

Pulsed Field Ablation for the Treatment of Malignant Lung Tumors

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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

DEVICE

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