An interventional study of The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system and The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system in Stage IA Lung Cancer, sponsored by Hangzhou Broncus Medical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Hangzhou Broncus Medical Co., Ltd. · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is the complete ablation rate at 6 months post-ablation. Secondary study endpoints are technical success rate, complete ablation rate at 12 months post-ablation, local control rate at 1, 2, and 3 years post-ablation, progression free survival, overall survival, and safety. Demographic data, clinical baseline characteristics, CT follow-up data, and safety data will be collected and recorded.
Exclusion Criteria:
Subjects receive bronchoscopy-guided RFA and undergo follow-up.
Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Subjects receive CT-guided RFA and undergo follow-up.
Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Complete ablation rate at 6 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.
Time frame: 6 months
Technical success rate
It is defined as the proportion of lesions which the ablation needle reached and successfully ablated to all lesions intended for ablation.
Time frame: Immediately after ablation
Complete ablation rate 12 months after ablation
It is defined as the proportion of lesions with complete ablation to all ablated lesions at 12 months after ablation.
Time frame: 12 months
Local control rate at 1 year, 2 years and 3 years after ablation
It is defined as the proportion of lesions with complete ablation and incomplete ablation to all ablated lesions at 1 year, 2 years, and 3 years after ablation.
Time frame: 1 year, 2 years and 3years
Progression free survival (PFS)
It is defined as the duration from the ablation to the first occurrence of disease progression or the death of the subject.
Time frame: 3 years
Overall survival (OS)
It is defined as the total time from the ablation to the death of the subject.
Time frame: 3 years
Safety
To assess the incidence of device- or procedure-related (serious) adverse events occurring during the study.
Time frame: 12 months
Plan to share: No
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Hangzhou Broncus Medical Co., Ltd.