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

NCT ID: NCT06739031

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2027-08-25

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEF Treatment

Group Type: EXPERIMENTAL

PEF Treatment

Intervention Type: DEVICE

PEF Energy ablation of lung tumors

Interventions

PEF Treatment

PEF Energy ablation of lung tumors

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Energenx Medical LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,

Shanghai, , China

Countries

China

Central Contacts

Sara Xu

Role: CONTACT

Phone: 021

Email: sara.xu@energenxmedical.com

Facility Contacts

Jiayuan Sun, M.D., PhD.

Role: primary

Other Identifiers

LC-101

Identifier Type: -

Identifier Source: org_study_id