NCT07638228Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 11 May 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 20 Oct 2026
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07638228
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 1 Sept 2025 to the primary completion date, 20 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
- Concurrent other malignancies with extensive metastasis, and expected survival \< 6 months.
- 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.
Other illness
- A patient will be excluded from participation in this clinical trial if any of the following conditions apply:
- 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.
- Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.
- Any other condition that the investigator considers inappropriate for enrollment.
Lab values
- 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.
Other
- Pregnancy, lactation, or planned pregnancy within one year.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.