An interventional study of Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter in Lung Neoplasms and Pulmonary Metastasis, sponsored by Hangzhou Broncus Medical Co., Ltd.. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Hangzhou Broncus Medical Co., Ltd. · Not applicable, Interventional, and Treatment
It is a multicenter, single group target value clinical trial to evaluate the safety and effectiveness of radiofrequency ablation for peripheral lung tumors under the conjunction of the pulmonary radiofrequency ablation system with the disposable pulmonary radiofrequency ablation catheter developed by Hangzhou Broncus Medical Co., Ltd.
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter. During the study, eligible subjects will be followed up intraoperatively, 24 hours after operation, before discharge/ 7 days after operation (whichever occurs first), 30 days (±7 days) after operation, 3 months (±7 days) after operation, 6 months (±15 days) after operation, 9 months (±15 days) after operation, and 12 months (±15 days) after operation.
Exclusion Criteria:
The subjects will first undergo interventional bronchoscopy to reach the target lesion through the bronchial pathway. Then the lung lesions will be treated with radiofrequency ablation using the pulmonary radiofrequency ablation system and the disposable pulmonary radiofrequency ablation catheter.
Device: Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter
The conjunction of the pulmonary RFA system with the disposable pulmonary RFA catheter developed by Hangzhou Broncus Medical Co., Ltd. is aim to specifically target lung tumors. The ablation catheter is designed to reach the tumor through the bronchial pathway.
Complete ablation rate of main lesions at 6 months
Six months after the overall ablation procedure, the proportion that subjects whose main lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time frame: Six months
Technical success rate (in terms of ablation operations)
It is defined as the proportion that the ablation operations in which the test device is successfully placed at the target lesion and the device is successfully withdrawn after treatment procedure, account for all ablation operations.
Time frame: Immediately after Each Operation
Complete ablation rate at 6 months (in terms of ablation lesions)
Six months after overall ablation procedure, the proportion that lesions completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Time frame: Six months
Complete ablation rate at 6 months (in terms of subjects)
Six months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time frame: Six months
Intrapulmonary progression-free survival rate at 6 months
Six months after overall ablation procedure, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Time frame: Six months
Complete ablation rate at 12 months (in terms of ablation lesions)
Twelve months after the completion of the overall ablation, the proportion that lesions which maintain completely ablated account for all evaluable lesions that receive radiofrequency ablation.
Time frame: Twelve months
Complete ablation rate at 12 months (in terms of subjects)
Twelve months after overall ablation procedure, the proportion that subjects whose all ablation lesions maintain completely ablated account for all evaluable subjects who receive radiofrequency ablation.
Time frame: Twelve months
Intrapulmonary progression-free survival rate at 1 year
Twelve months after the completion of the overall ablation, the proportion that subjects with no progression in the lung (the original ablation lesions maintain completely ablated, no metastasis of hilar lymph nodes, and no new lesions) account for all evaluable subjects who receive radiofrequency ablation.
Time frame: Twelve months
Overall survival rate (OS) at 1 year
It is defined as the proportion of surviving subjects at 1 year from enrollment.
Time frame: Twelve months
Quality of life (QoL)
The QoL changes are evaluated according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ C30) assessment scale during the follow-up. The EORCT QLQ C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease.
Time frame: Twelve months
Safety
All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0 (if applicable). Related and possible related AEs and SAEs will be determined and evaluated.
Time frame: Twelve months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hangzhou Broncus Medical Co., Ltd.