Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Mali… (NCT07638228) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules
China5 participantsStarted 2025-09-01
Plain-language summary
To evaluate the safety and efficacy of the wideband electric pulse tumor ablation system, for the treatment of malignant pulmonary nodules.
Subjects will first undergo interventional bronchoscopy to access the target lesion via the bronchial pathway. During the procedure, the physician will perform percutaneous needle placement under CT guidance and use IRE (irreversible electroporation) to ablate the pulmonary lesion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years.
. Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:
. Stage IA primary non-small cell lung cancer; or
. Intrapulmonary metastatic tumors with the primary lesion well controlled.
. Solitary lesion size ≤ 2 cm, and total number of lesions ≤ 3.
. ECOG performance status score ≤ 2.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'active, not recruiting' — does that mean it's too late for me to participate, or is it worth asking the study team directly whether any spots might open up?
2The trial uses something called a 'wideband electric pulse' system to ablate lung nodules — how does this approach compare to other ablation methods or surgery that I might already be eligible for as a standard treatment?
3The main thing this trial is measuring is whether the nodule is successfully ablated one month after the procedure — what happens with my monitoring and care after that one-month check-in, and how long would I be followed for?
4Since this trial is listed as Phase NA, what does that mean for how much is already known about the safety and effectiveness of this specific ablation device in people with lung cancer?
5Given the location of my nodule and my overall lung function, would you consider me a good candidate for an ablation-based approach like this, or would another treatment path be safer or more proven for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate of nodule ablation at 1 month after ablation
. Severe bleeding tendency, platelet count \< 50×10⁹/L, or coagulation dysfunction (prothrombin time \> 18 s, prothrombin activity \< 40%) that cannot be corrected in the short term.
. Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
. Infectious or radiation-induced inflammation around the lesion, poorly controlled skin infection at the puncture site, systemic infection, or fever \> 38.5°C.
. Severe dysfunction of the liver, kidney, heart, lung, or brain; severe anemia, dehydration, or serious nutritional/metabolic disorders that cannot be corrected or improved in the short term.
. Poorly controlled malignant pleural effusion.
. Distant metastasis of lung cancer.
. Concurrent other malignancies with extensive metastasis, and expected survival \< 6 months.
. Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.