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Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures.
In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers | Investigational devices are Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered | Device | Investigational devices encompassing all models of the Cartridges for Disposable Endoscopic Linear Cutting Staplers, as well as Staplers utilized in conjunction with the Cartridges specified in the Study Plan (Plan number: WEKD-QS-PMCF). |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis success rate | According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis. | The investigation sites will be collected from January 2023 to June 2024. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic bleeding rate | The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded. | |
| Anastomotic leakage rate | The incidence of leakage during day of operation and 6 months after operation was recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | The investigation sites will be collected from January 2023 to June 2024. | |
| Intraoperative bleeding | The investigation sites will be collected from January 2023 to June 2024. | |
Inclusion Criteria:
Exclusion Criteria:
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Cartridges of Disposable Endoscopic Linear Cutting Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments are applied in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. They must be used in combination with Disposable Powered Endoscopic Linear Cutting Staplers or Disposable Endoscopic Linear Cutting Staplers manufactured by the Company.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke Zhou | Contact | +86 18118447767 | ke.zhou@care-real.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers | Recruiting | Ningbo | Zhejiang | 315101 | Chile |
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| Anastomotic stenosis rate | The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded. |
| Intraoperative conversion (due to device reasons) |
| The investigation sites will be collected from January 2023 to June 2024. |
| Length of hospitalization | The investigation sites will be collected from January 2023 to June 2024. |