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| Name | Class |
|---|---|
| Jiangsu Channel Medical Device Co., Ltd. | UNKNOWN |
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This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.
The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable endoscope linear cutting stapler and components | Device | to use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| anastomosis success rate | According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100% | within six months after surgery |
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Inclusion Criteria:
gender unlimited, age unlimited â‘¡ open or endoscopic surgery â‘¢ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
Exclusion Criteria:
patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;
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Patients who need open or endoscopic surgery using the study device for resection, transection and anastomosis for liver, bronchial tissue, stomach and intestines. Those who meet the inclusion criteria and don't meet the exclusion criteria will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhengliang Tu | Contact | 13600513557 | tuzhl@sina.com | |
| Tao Zhang | Contact | 13500206389 |
| Name | Affiliation | Role |
|---|---|---|
| zhengliang Tu | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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