An interventional study of Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter in Non-Small Cell Lung Cancer and Pulmonary Metastases, sponsored by Shanghai Chest Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
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.
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
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.
Device: Pulsed Field Ablation System and Single-Use Pulsed Field Ablation Catheter
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.
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%.
Time frame: 6 months after completion of the ablation procedure
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 7 days or before discharge, and 1, 3, and 6 months after completion of the overall ablation procedure
Incidence of Adverse Events and Serious Adverse Events
The number and percentage of participants experiencing adverse events and serious adverse events during the study. Adverse events will be evaluated using CTCAE version 6.0 when applicable. All adverse events, serious adverse events, device-related adverse events, and procedure-related adverse events will be summarized separately. The severity, outcome, and relationship of each event to the investigational devices and ablation procedure will be assessed and recorded.
Time frame: From the start of the ablation procedure through 6 months after completion of the overall ablation procedure
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 305 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 123. This study's planned 24 months is below that.
Counting every sponsor, half of 320 studies reached it within 52 months; a quarter within 28 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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