Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules
Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules: A First-in-Human (FIM) Trial
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A pulmonary nodule (PN) refers to a round or irregular lesion within the lung with a diameter ≤3 cm. Radiologically, it appears as a focus of increased density, which may be solitary or multiple, with well-defined or ill-defined margins. The malignant probability of pulmonary nodules varies according to their density, and based on nodule density, they are classified into three types: solid nodules, part-solid nodules, and ground-glass nodules . Currently, lung cancer is the most common and deadliest cancer worldwide, and is also one of the most prevalent malignant tumors in China. Malignant pulmonary nodules are considered an early manifestation of lung cancer; therefore, early detection, early diagnosis, and early treatment are key to improving patient survival.
Current clinical treatment options for pulmonary nodules include surgical resection and ablation techniques, such as radiofrequency ablation, microwave ablation, and cryoablation. However, for pulmonary nodules located in special sites, hot or cold ablation may easily damage the pleura, leading to bronchopleural fistula, and often results in incomplete ablation due to the heat sink effect.
Irreversible electroporation (IRE) employs a mechanism and technical application features completely different from other physical ablation methods. This technique delivers high-voltage electrical pulses via electrode needles to create a high-electric-field ablation zone. Within this zone, numerous irreversible nanoscale pores are formed in the cell membrane, disrupting the intra- and extracellular environment balance and inducing apoptosis, thereby permanently destroying tissue cells. During IRE ablation, only the lipid bilayer of the cell membrane within the ablated area is disrupted, while critical structures such as blood vessels are not severely damaged. Owing to this unique ablation characteristic, IRE offers irreplaceable advantages in the treatment of various diseases, including short treatment time, applicability to more complex conditions, preservation of vital structures within the treatment zone, complete ablation, and well-defined ablation margins.
This clinical trial aims to evaluate the safety and efficacy of the wideband electric pulse tumor ablation system (manufactured by Hangzhou Win-Once Medical Technology Co., Ltd.) in treating malignant pulmonary nodules, providing reference data for the subsequent formal trial.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
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:
- 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.
- The target lesion has received prior local treatments (e.g., radiotherapy, ablation) within 3 months before enrollment.
- Participation in any drug and/or medical device clinical trial within 1 month before enrollment.
- Pregnancy, lactation, or planned pregnancy within one year.
- Any other condition that the investigator considers inappropriate for enrollment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Experimental Group: Patients treated by wideband electric pulse tumor ablation system
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Anesthesia management: Intravenous anesthesia Surgical procedure:
Guidance approach:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Success rate of nodule ablation at 1 month after ablation
Tidsramme: 1 month
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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.
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1 month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Secondary Efficacy Endpoints:
Tidsramme: 6 months
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(1) Technical success rate: Defined as the proportion of ablation procedures in which the investigational device is successfully placed in the target lesion, completes ablation, and is successfully withdrawn after treatment, relative to all ablation procedures performed.
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6 months
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Secondary Outcome Measure
Tidsramme: 6 month
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Complete nodule ablation rate at 3 and 6 months post-ablation.
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6 month
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Secondary Outcome Measure
Tidsramme: 6 month
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Nodule recurrence rate at 6 months post-ablation.
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6 month
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Secondary Outcome Measure
Tidsramme: 6 month
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Progression-free survival rate at 6 months post-ablation.
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6 month
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SirRRSH2025- 0602
Plan for individuelle deltagerdata (IPD)
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