Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors

Not Applicable

Not yet recruiting

• Conditions: NSCLC

• Registration Number: NCT06739031
• Lead Sponsor: Energenx Medical LTD.

Brief Summary

The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.

The main questions it aims to answer are:

* Safety of PEF treatment of early-stage unreseectable NSCLC patients.

* Locoregional control of ablated lesions.

* Survival and quality of life assessment of early-stage unreseectable NSCLC patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2024-12-25
• Primary Completion: 2026-12-25
• Study Completion: 2027-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
6-month complete ablation rate	6 months

Secondary Outcome Measures

Name	Time	Method
Technical success rate	immediately after the PEF ablation treatment
6-month pulmonary progression-free survival rate	6 months after the first PEF ablation treatment
12-month complete ablation rate	12 months after the first PEF ablation treatment
12-month pulmonary progression-free survival rate	12 months after the first PEF ablation treatment	The proportion of subjects with no pulmonary progression (the first ablation lesion maintained no progression, no hilar lymph node metastasis, no new lesions) accounted for the proportion of evaluable subjects who received ablation
12-month overall survival rate	12 months after the first PEF ablation treatment

Trial Locations

Locations (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,; 🇨🇳 Shanghai, China