Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT06969014
The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Microwave ablation of lung tumors
Time frame: 6 months
6 months after ablation surgery, the proportion of patients with the main lesion maintained complete ablation among all evaluable patients who received transbronchial microwave ablation treatment.
Time frame: 12 months
This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months and 12 months after transbronchial MWA.
Time frame: 12 months
This refers to the proportion of patients with all treated lesions completely ablated in all patients who received transbronchial MWA at 6 months and 12 months after transbronchial MWA.
Time frame: 12 months
The proportion of patients who are progression-free (without disease progression or death from any cause) at 12 months post-procedure in the total evaluable patients who received transbronchial MWA.
Time frame: 12 months
The proportion of subjects who remain alive from the start of treatment until 1 year post-treatment.
Time frame: 12 months
The proportion of subjects who remain local progression-free from the start of treatment until 6,12 months post-treatment.
Time frame: immediately after transbronchial MWA
It is defined as the proportion of ablation treatment surgeries where the ablation instrument is successfully placed in the target lesion and the ablation instrument is successfully removed after the completion of the treatment procedure among all ablation treatment surgeries.
Time frame: immediately after transbronchial MWA
Evaluate whether the microwave therapy device's microwave output is normal and whether the cooling circulation system is normal. Evaluate whether the water flow of the disposable microwave ablation electrode is smooth, whether the rod temperature is normal, whether there is tissue adhesion during ablation, and whether there is coolant leakage.
Time frame: 12 months
The Eastern Cooperative Oncology Group (ECOG) scoring criteria were used to evaluate the physical performance status of subjects during the screening period, 7 days after treatment or before discharge, 1 month after treatment, 3 months after treatment, 6 months after treatment, and 12 months after treatment. A decrease in the score ≥1 before and after was defined as an improvement in performance status, an increase of ≥1 point was defined as a decrease in performance status, and no change in the score was stable.
Time frame: 12 months
All adverse events were recorded and evaluated according to CTCAE v5.0 (if applicable), and the relevance to the device itself and the procedure was evaluated. The incidence of device-related and procedure-related adverse events and serious adverse events was calculated.
Contact information is provided by the study sponsor or research team.
Shanghai Chest Hospital
Other
Treatment of Pulmonary Tumors Using Disposable Microwave Ablation Electrodes and a Microwave Ablation System Guided by Bronchoscopy: An Exploratory Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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