Malignant Pulmonary NodulesNCT07638228
Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules
A study testing wideband electric pulse tumor ablation system treatment in people with Malignant Pulmonary Nodules and Lung Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pulmonary Nodules, Lung Cancer
- What is being tested?
- wideband electric pulse tumor ablation system treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Malignant Pulmonary Nodules, Lung Cancer
- Being tested
- wideband electric pulse tumor ablation system treatment
- Keywords
- malignant pulmonary nodules, Lung Cancer, effectiveness and safety
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wideband electric pulse tumor ablation system treatmentDevice
Anesthesia management: Intravenous anesthesia
Surgical procedure:
- Intraoperative monitoring of blood pressure, electrocardiogram (ECG), and oxygen saturation.
- Insertion of the ablation catheter/needle into the nodule position.
- Application of IRE to perform ablation of the pulmonary lesion.
Guidance approach:
- The subject will first undergo interventional bronchoscopy to reach the target lesion via the bronchial pathway.
- Intraoperative percutaneous needle placement under CT guidance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Patients treated by wideband electric pulse tumor ablation system | Experimental | Not described Receives: Device: wideband electric pulse tumor ablation system treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of nodule ablation at 1 month after ablation
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.
Measured: 1 month
Secondary outcomes (4)
Secondary Efficacy Endpoints:
(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.
Measured: 6 months
Secondary Outcome Measure
Complete nodule ablation rate at 3 and 6 months post-ablation.
Measured: 6 month
Secondary Outcome Measure
Nodule recurrence rate at 6 months post-ablation.
Measured: 6 month
Secondary Outcome Measure
Progression-free survival rate at 6 months post-ablation.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Sep 2025
- Primary completion20 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638228
- Sponsor's protocol ID
- SirRRSH2025- 0602
- Status last verified
- Mar 2026
- First submitted
- 11 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules: A First-in-Human (FIM) Trial
- ClinicalTrials.gov ID
- NCT07638228
- Acronym / sponsor ID
- SirRRSH2025- 0602
- Conditions
- Malignant Pulmonary Nodules, Lung Cancer
- Keywords
- malignant pulmonary nodules, Lung Cancer, effectiveness and safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Patients treated by wideband electric pulse tumor ablation system | Experimental | Device: wideband electric pulse tumor ablation system treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wideband electric pulse tumor ablation system treatmentAnesthesia 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. | Device | Experimental Group: Patients treated by wideband electric pulse tumor ablation system |
Primary outcome
Success rate of nodule ablation at 1 month after ablation
Time frame: 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.
4 secondary outcomes
Secondary Efficacy Endpoints:
Time frame: 6 months
Secondary Outcome Measure
Time frame: 6 month
Secondary Outcome Measure
Time frame: 6 month
Secondary Outcome Measure
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wideband electric pulse tumor ablation system treatment in people with Malignant Pulmonary Nodules and Lung Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of nodule ablation at 1 month after ablation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.