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NCT Number: NCT06739031

Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China

Location contact

Jiayuan Sun, M.D., PhD.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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):

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

Treatment and study plan

PEF Treatment

Device

PEF Energy ablation of lung tumors

Primary outcomes

  1. 6-month complete ablation rate

    Time frame: 6 months

Secondary outcomes

  1. Technical success rate

    Time frame: immediately after the PEF ablation treatment

  2. 6-month pulmonary progression-free survival rate

    Time frame: 6 months after the first PEF ablation treatment

  3. 12-month complete ablation rate

    Time frame: 12 months after the first PEF ablation treatment

  4. 12-month pulmonary progression-free survival rate

    Time frame: 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

  5. 12-month overall survival rate

    Time frame: 12 months after the first PEF ablation treatment

Other outcomes

  1. Safety of Intervention

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Xu

CONTACT

[email protected]

021

Sponsors and collaborators

Lead sponsor

Energenx Medical LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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