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

A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC
• Intervention / Treatment: Device: PEF Treatment

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Xu; Phone Number: 021; Email: sara.xu@energenxmedical.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,
    • Contact: Jiayuan Sun, M.D., PhD.; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria (all requirements must be met at the same time):

1. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.

Exclusion criteria (if any of the above conditions are met, the patient will be excluded):

1. The subject cannot tolerate or refuses general anesthesia;
2. Has a history of severe allergic reactions;
3. Has contraindications to bronchoscopy or refuses bronchoscopy;

5. Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR>1.5 or APTT>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets <50×10^9/L; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEF Treatment	Device: PEF Treatment; PEF Energy ablation of lung tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-month complete ablation rate	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 months after the first PEF ablation treatment
12-month overall survival rate		12 months after the first PEF ablation treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Intervention	All adverse events were recorded and evaluated according to CTCAE v5.0 (if applicable), and the relevance to the device itself and the treatment was evaluated. The incidence of device-related and surgical treatment-related adverse events and serious adverse events was calculated	12 months

Collaborators and Investigators

• Sponsor: Energenx Medical LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): August 25, 2027

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LC-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No