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Respiratory Tract Diseases

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.

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.

Pulmonary Radiofrequency Ablation System and the Disposable Pulmonary Radiofrequency Ablation Catheter

Shiyue Li, MD

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.

Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors

A Multicenter, Single Group Target Value Clinical Study to Evaluate Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors

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.

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ablation operations in which the test device is successfully placed at the target lesion and the device is successfully withdrawn after treatment procedure, account for all ablation operations.

Six months after overall ablation procedure, the proportion that lesions completely ablated account for all evaluable lesions that receive radiofrequency ablation.

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.

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.

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.

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.

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.

It is defined as the proportion of surviving subjects at 1 year from enrollment.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors	NCT04619472	Lung Neoplasms Pulmonary Metas...	Pulmonary Radio...	18 Years -	Hangzhou Broncus Medical Co., Ltd.
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors	NCT04619472	Lung Neoplasms Pulmonary Metas...	Pulmonary Radio...	18 Years -	Hangzhou Broncus Medical Co., Ltd.
Safety and Effectiveness of Radiofrequency Ablation System in the Treatment of Peripheral Lung Tumors	NCT04619472	Lung Neoplasms Pulmonary Metas...	Pulmonary Radio...	18 Years -	Hangzhou Broncus Medical Co., Ltd.

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