Pulsed field ablation through a bronchoscope for cancerous lung tumors
Tests electrical pulses to destroy lung tumors in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: Pulsed Field Ablation for the Treatment of Malignant Lung Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with small early-stage lung cancer, or lung metastases, who cannot or will not have surgery or radiotherapy and whose tumor can be reached through the airways.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Primary peripheral non-small cell lung cancer at stage T1N0M0 (stage IA), including new tumors after surgery and multiple primary lung cancers. Or lung metastases where the original tumor was fully removed and the largest tumor is 3 cm (1.2 in) or less. No more than three lung tumors.
- Earlier treatment
- The person refuses surgery or is not fit enough for it. The person also refuses radiotherapy or is not fit for it, did not respond to earlier radiotherapy, or got worse after radiotherapy. For metastases, the original tumor must have been completely removed.
Main reasons for not taking part
- Severe bleeding tendency or a blood clotting disorder that cannot be corrected
- Spread to lymph nodes or outside the lungs (unless controlled by local treatment)
- Pacemaker, defibrillator or other electronic device or metal part in or near the treatment area
- Serious heart rhythm problems in the past 2 years, or a heart rate below 45 beats per minute
- Pregnancy or breastfeeding, or planning pregnancy during the study
Read by machine on 11 November 2026.
Where in China
- Shanghai Chest HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Chest Hospital
- Trial code
- NCT07889297
- Record updated
- 22 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; The target lesion has received radiotherapy within the previous 6 months; Current participation in another clinical study involving an investigational product; Severe bleeding tendency or an uncorrectable coagulation disorder, including a prothrombin time greater than 18 seconds or prothrombin activity less than 40%; 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; 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; Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this study; 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; Extensive pulmonary metastases with an estimated survival of less than 3 months; Eastern Cooperative Oncology Group (ECOG) performance status greater than 2; Contraindication to bronchoscopy; Contraindication to general anesthesia; Pregnancy or breastfeeding, or a female or male participant planning pregnancy or conception during the study.