Non-Small Cell Lung CancerNCT07889297
Pulsed Field Ablation for the Treatment of Malignant Lung Tumors
A study testing Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter in people with Non-Small Cell Lung Cancer and Pulmonary Metastases, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This prospective, single-center, single-arm exploratory study will evaluate the safety and effectiveness of a pulsed field ablation system and a single-use pulsed field ablation catheter for the treatment of malignant lung tumors. Pulsed field ablation uses short electrical pulses to ablate targeted tumor tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Pulmonary Metastases
- What is being tested?
- Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2028
- 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 or older.
- Pathologically confirmed primary peripheral non-small cell lung cancer with a clinical stage of T1N0M0, stage IA, including newly developed tumors after surgery and multiple primary lung cancers; or pulmonary metastatic tumors for which the primary lesion has been completely resected and the maximum tumor diameter is 3 cm or less.
- No more than three lung tumors.
- The participant refuses surgery or is considered unsuitable for surgery.
- The participant refuses or is considered unsuitable for radiotherapy, has not responded to previous radiotherapy, or has experienced disease progression after radiotherapy.
- In the investigator's judgment, the target lesion can be reached through the bronchial route and pulsed field ablation is technically feasible.
- The participant voluntarily agrees to participate, provides written informed consent, and is able and willing to comply with all study procedures.
Who cannot join
- Severe bleeding tendency or an uncorrectable coagulation disorder, including a prothrombin time greater than 18 seconds or prothrombin activity less than 40%.
- Platelet count less than 70 x 10^9/L, or anticoagulant and/or antiplatelet medication that has not been discontinued for at least 1 week before ablation, except for prophylactic preoperative use of low-molecular-weight heparin.
- Imaging performed within 1 month before the procedure showing lymph node metastasis or extrapulmonary metastasis, except for extrapulmonary metastases that have been controlled by local treatment.
- Extensive pulmonary metastases with an estimated survival of less than 3 months.
- A condition considered to confer a high risk for the ablation procedure, including severe comorbidities, active infection, severe pulmonary arterial hypertension, severe heart disease, severe hypertension, or severe respiratory failure.
- A history of arrhythmia within the previous 2 years, including atrial tachyarrhythmia or any ventricular tachyarrhythmia; a history of second-degree Mobitz type II or third-degree atrioventricular block; or sinus bradycardia with a heart rate below 45 beats per minute.
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- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.
- The target lesion has received radiotherapy within the previous 6 months.
- The shortest distance between the target lesion and the trachea, main bronchus, esophagus, branches of the aortic arch, main pulmonary artery, right or left pulmonary artery trunk, or heart is less than 1 cm; or the distance between the pleural margin of the tumor and the pleura is less than 1 cm.
- A cardiac pacemaker, implantable cardioverter-defibrillator, or another electronic device or metal component is present within or near the planned ablation area.
- Contraindication to bronchoscopy.
- Contraindication to general anesthesia.
- Pregnancy or breastfeeding, or a female or male participant planning pregnancy or conception during the study.
- Current participation in another clinical study involving an investigational product.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Jiayuan Sun, +86 18017321598, jysun1976@163.com
About this study
Official title: An Exploratory Clinical Trial to Evaluate a Pulsed Field Ablation System and a Single-Use Pulsed Field Ablation Catheter for the Treatment of Malignant Lung Tumors
This prospective, single-center, single-arm exploratory study will evaluate the safety and effectiveness of a pulsed field ablation system and a single-use pulsed field ablation catheter for the treatment of malignant lung tumors. Pulsed field ablation uses short electrical pulses to ablate targeted tumor tissue.
The study plans to enroll 15 adult participants at Shanghai Chest Hospital. Each participant will undergo bronchoscopic pulsed field ablation and will be followed for 6 months after the procedure. The main outcome is the proportion of treated lesions showing complete ablation at 6 months. Technical success, tumor control, survival, quality of life, and adverse events will also be evaluated.
Read the detailed description
This is a prospective, single-center, single-arm, open-label exploratory clinical study. Approximately 15 adult participants with eligible primary or metastatic malignant lung tumors will be enrolled.
During the procedure, a single-use pulsed field ablation catheter will be advanced through the bronchial route to the target lesion. The pulsed field ablation system will then deliver electrical pulses to ablate the tumor tissue. If clinically appropriate, supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit.
Participants will be evaluated before the procedure, during the procedure, approximately 24 hours after the procedure, before discharge or 7 days after the procedure, and at 1, 3, and 6 months. Effectiveness assessments will include complete ablation of the treated lesions, technical success, patient-level complete ablation, intrapulmonary progression-free survival, overall survival, and quality of life. Safety will be evaluated by recording adverse events and serious adverse events throughout the study.
- Conditions
- Non-Small Cell Lung Cancer, Pulmonary Metastases
- Being tested
- Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter
- Keywords
- Pulsed Field Ablation, Pulsed Electric Field Ablation, Bronchoscopic Ablation, Lung Tumor, Tumor Ablation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation System and Single-Use Pulsed Field Ablation CatheterDevice
The pulsed field ablation system is used together with a single-use pulsed field ablation catheter. The catheter is advanced through the bronchial route to the target lung lesion, and the system delivers pulsed electrical energy to ablate the targeted tumor tissue. Device placement and ablation are performed according to the study protocol. Supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit if clinically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation | Experimental | Participants will receive bronchoscopic pulsed field ablation for eligible malignant lung tumors using a pulsed field ablation system and a single-use pulsed field ablation catheter. Supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit if clinically appropriate. Participants will be followed for 6 months after the initial procedure. Receives: Device: Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Ablation Rate at 6 Months (Lesion-Level)
The percentage of evaluable treated lung lesions that maintain complete ablation at 6 months after completion of the ablation procedure. Complete ablation is assessed by computed tomography (CT) and is defined as a target lesion that has decreased or remained unchanged in size and shows no contrast enhancement. Nonenhancing cavities, solid nodules, atelectasis, or fibrosis may be considered findings consistent with complete ablation according to the protocol-defined criteria. The rate is calculated as the number of evaluable lesions meeting the complete ablation criteria divided by the total number of evaluable ablated lesions, multiplied by 100%.
Measured: 6 months after completion of the ablation procedure
Secondary outcomes (5)
Technical Success Rate
The percentage of ablation procedures in which the investigational devices are successfully advanced to the target lesion, the planned ablation procedure is completed, and the devices are successfully withdrawn. The rate is calculated as the number of technically successful procedures divided by the total number of ablation procedures, multiplied by 100%.
Measured: Immediately after each ablation procedure
Complete Ablation Rate at 6 Months (Participant-Level)
The percentage of evaluable participants for whom all treated lung lesions maintain complete ablation at 6 months after completion of the overall ablation procedure. Complete ablation is assessed by CT and is defined as a target lesion that has decreased or remained unchanged in size and shows no contrast enhancement.
Measured: 6 months after completion of the overall ablation procedure
Intrapulmonary Progression-Free Survival Rate at 6 Months
The percentage of evaluable participants without intrapulmonary disease progression at 6 months. Absence of intrapulmonary progression is defined as maintenance of complete ablation of the originally treated lesions, no hilar lymph node metastasis, and no new intrapulmonary lesions.
Measured: 6 months after completion of the overall ablation procedure
Overall Survival Rate at 6 Months
The percentage of enrolled participants who are alive at 6 months after enrollment.
Measured: 6 months after enrollment
Change From Baseline in EORTC QLQ-C30 Scores
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores at each post-treatment visit and changes from baseline will be summarized according to the standard scoring procedures for the questionnaire.
Measured: Baseline, 7 days or before discharge, and 1, 3, and 6 months after completion of the overall ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889297
- Sponsor's protocol ID
- CSP26002
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate a Pulsed Field Ablation System and a Single-Use Pulsed Field Ablation Catheter for the Treatment of Malignant Lung Tumors
- ClinicalTrials.gov ID
- NCT07889297
- Acronym / sponsor ID
- CSP26002
- Conditions
- Non-Small Cell Lung Cancer, Pulmonary Metastases
- Keywords
- Pulsed Field Ablation, Pulsed Electric Field Ablation, Bronchoscopic Ablation, Lung Tumor, Tumor Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Oct 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.
This prospective, single-center, single-arm exploratory study will evaluate the safety and effectiveness of a pulsed field ablation system and a single-use pulsed field ablation catheter for the treatment of malignant lung tumors. Pulsed field ablation uses short electrical pulses to ablate targeted tumor tissue.
The study plans to enroll 15 adult participants at Shanghai Chest Hospital. Each participant will undergo bronchoscopic pulsed field ablation and will be followed for 6 months after the procedure. The main outcome is the proportion of treated lesions showing complete ablation at 6 months. Technical success, tumor control, survival, quality of life, and adverse events will also be evaluated.
Detailed description
This is a prospective, single-center, single-arm, open-label exploratory clinical study. Approximately 15 adult participants with eligible primary or metastatic malignant lung tumors will be enrolled.
During the procedure, a single-use pulsed field ablation catheter will be advanced through the bronchial route to the target lesion. The pulsed field ablation system will then deliver electrical pulses to ablate the tumor tissue. If clinically appropriate, supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit.
Participants will be evaluated before the procedure, during the procedure, approximately 24 hours after the procedure, before discharge or 7 days after the procedure, and at 1, 3, and 6 months. Effectiveness assessments will include complete ablation of the treated lesions, technical success, patient-level complete ablation, intrapulmonary progression-free survival, overall survival, and quality of life. Safety will be evaluated by recording adverse events and serious adverse events throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation | Experimental | Device: Pulsed Field Ablation System and Single-Use Pulsed Field Ablation CatheterParticipants will receive bronchoscopic pulsed field ablation for eligible malignant lung tumors using a pulsed field ablation system and a single-use pulsed field ablation catheter. Supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit if clinically appropriate. Participants will be followed for 6 months after the initial procedure. |
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 or older.
- Pathologically confirmed primary peripheral non-small cell lung cancer with a clinical stage of T1N0M0, stage IA, including newly developed tumors after surgery and multiple primary lung cancers; or pulmonary metastatic tumors for which the primary lesion has been completely resected and the maximum tumor diameter is 3 cm or less.
- No more than three lung tumors.
- The participant refuses surgery or is considered unsuitable for surgery.
- The participant refuses or is considered unsuitable for radiotherapy, has not responded to previous radiotherapy, or has experienced disease progression after radiotherapy.
Key exclusion criteria (15 listed)
- Severe bleeding tendency or an uncorrectable coagulation disorder, including a prothrombin time greater than 18 seconds or prothrombin activity less than 40%.
- Platelet count less than 70 x 10^9/L, or anticoagulant and/or antiplatelet medication that has not been discontinued for at least 1 week before ablation, except for prophylactic preoperative use of low-molecular-weight heparin.
- Imaging performed within 1 month before the procedure showing lymph node metastasis or extrapulmonary metastasis, except for extrapulmonary metastases that have been controlled by local treatment.
- Extensive pulmonary metastases with an estimated survival of less than 3 months.
- A condition considered to confer a high risk for the ablation procedure, including severe comorbidities, active infection, severe pulmonary arterial hypertension, severe heart disease, severe hypertension, or severe respiratory failure.
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 |
|---|---|---|
| Pulsed Field Ablation System and Single-Use Pulsed Field Ablation CatheterThe pulsed field ablation system is used together with a single-use pulsed field ablation catheter. The catheter is advanced through the bronchial route to the target lung lesion, and the system delivers pulsed electrical energy to ablate the targeted tumor tissue. Device placement and ablation are performed according to the study protocol. Supplementary ablation of the original treated lesion may be performed at the 3-month follow-up visit if clinically appropriate. | Device | Pulsed Field Ablation |
Primary outcome
Complete Ablation Rate at 6 Months (Lesion-Level)
Time frame: 6 months after completion of the ablation procedure
The percentage of evaluable treated lung lesions that maintain complete ablation at 6 months after completion of the ablation procedure. Complete ablation is assessed by computed tomography (CT) and is defined as a target lesion that has decreased or remained unchanged in size and shows no contrast enhancement. Nonenhancing cavities, solid nodules, atelectasis, or fibrosis may be considered findings consistent with complete ablation according to the protocol-defined criteria. The rate is calculated as the number of evaluable lesions meeting the complete ablation criteria divided by the total number of evaluable ablated lesions, multiplied by 100%.
5 secondary outcomes
Technical Success Rate
Time frame: Immediately after each ablation procedure
Complete Ablation Rate at 6 Months (Participant-Level)
Time frame: 6 months after completion of the overall ablation procedure
Intrapulmonary Progression-Free Survival Rate at 6 Months
Time frame: 6 months after completion of the overall ablation procedure
Overall Survival Rate at 6 Months
Time frame: 6 months after enrollment
Change From Baseline in EORTC QLQ-C30 Scores
Time frame: Baseline, 7 days or before discharge, and 1, 3, and 6 months after completion of the overall ablation procedure
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 22 Oct 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.
Jiayuan Sun, MD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter in people with Non-Small Cell Lung Cancer and Pulmonary Metastases, run by Shanghai Chest 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 15 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: opening soon, as of the sponsor's last update on 22 Oct 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?
Contact Jiayuan Sun, MD (+86 180 1732 1598, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Ablation Rate at 6 Months (Lesion-Level) (time frame: 6 months after completion of the ablation procedure). 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 22 Oct 2026.