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Obtaining medical device market approval through the predicate device comparison route.
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Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment of primary liver cancer.
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental | Subjects will be treated with microwave ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microwave ablation | Device | ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete tumor ablation rate | the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation. | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| First complete tumor ablation rate | the percentage of subjects who did not undergo the second one month after the operation accounted for all the ablation trials. | 1 month after surgery |
| Complete ablation rate of lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaojun Teng, Doctor | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
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prospective, multi-center, single-group target value
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the percentage of lesions that are completely ablated to all lesions undergoing ablation.
| 1 month after surgery |
| The First Affiliated Hospital of Fujian Medical University |
| Fuzhou |
| Fujian |
| 350005 |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Ruijin Hospital,Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The Central Hospital of Lishui City | Lishui | Zhejiang | 323000 | China |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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