wideband electric pulse tumor ablation system treatment
wideband electric pulse tumor ablation system treatment: Anesthesia management: Intravenous anesthesia
Surgical procedure:
1. Intraoperative monitoring of blood pressure, electrocardiogram (ECG), and oxygen saturation.
2. Insertion of the ablation catheter/needle into the nodule position.
3. Application of IRE to perform ablation of the pulmonary lesion.
Guidance approach:
1. The subject will first undergo interventional bronchoscopy to reach the target lesion via the bronchial pathway.
2. Intraoperative percutaneous needle placement under CT guidance.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years.
2. Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:
1. Stage IA primary non-small cell lung cancer; or
2. Intrapulmonary metastatic tumors with the primary lesion well controlled.
3. Solitary lesion size ≤ 2 cm, and total number of lesions ≤ 3.
4. ECOG performance status score ≤ 2.
Patients who are ineligible for surgery/radiotherapy, or who refuse surgery/radiotherapy, or who voluntarily participate.
Exclusion Criteria:
A patient will be excluded from participation in this clinical trial if any of the following conditions apply:
1. 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.
2. Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
3. Infectious or radiation-induced inflammation around the lesion, poorly controlled skin infection at the puncture site, systemic infection, or fever \> 38.5°C.
4. 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.
5. Poorly controlled malignant pleural effusion.
6. Distant metastasis of lung cancer.
7. Concurrent other malignancies with extensive metastasis, and expected survival \< 6 months.
8. Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.
9. The target lesion has received prior local treatments (e.g., radiotherapy, ablation) within 3 months before enrollment.
10. Participation in any drug and/or medical device clinical trial within 1 month before enrollment.
11. Pregnancy, lactation, or planned pregnancy within one year.
12. Any other condition that the investigator considers inappropriate for enrollment.
Primary outcome measure(s)
Success rate of nodule ablation at 1 month after ablation — 1 month Success rate of nodule ablation at 1 month after ablation Definition of ablation success:No obvious enhancement in the ablated area on contrast-enhanced CT, indicating complete ablation. The success rate is assessed per nodule, and each nodule is evaluated independently.
Trial sites (1)
Facility
City
Region
Status
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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