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| Name | Class |
|---|---|
| Canyon Medical | UNKNOWN |
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The purpose of the study is to evaluate the efficacy and safety of transbronchial microwave ablation for lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transbronchial microwave ablation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave ablation | Device | Microwave ablation of lung tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate of main lesion at 6 months post-procedure | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete ablation rate at 6 months, 12 months post-procedure (calculated in units of ablation lesions) | This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months and 12 months after transbronchial MWA. | 12 months |
| Complete ablation rate at 6 months, and 12 months post-procedure (calculated in units of patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of intervention | 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun | Contact | +86-021-22200000 | 1511 | jysun1976@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Transbronchial MWA
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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. |
| 12 months |
| Progression-free survival rate at 12 months post-procedure | 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. | 12 months |
| Overall survival rate at 12 months post-procedure | The proportion of subjects who remain alive from the start of treatment until 1 year post-treatment. | 12 months |
| Local progression-free survival rate at 6,12 months post-procedure | The proportion of subjects who remain local progression-free from the start of treatment until 6,12 months post-treatment. | 12 months |
| Technical success rate | 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. | immediately after transbronchial MWA |
| Safety evaluation of medical device use | 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. | immediately after transbronchial MWA |
| ECOG Score | 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. | 12 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |