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This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable endoscopic linear cutter stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable endoscopic linear cutter stapler | Device | Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis success rate | The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records. | the investigation sites will be collected from January 2023 to September 2024. |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Confirmed by surgical records and anesthesia sheets. | The investigation sites will be collected from January 2023 to September 2024. |
| Amount of intraoperative blood loss | Confirmed by surgical records/nursing notes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc. | From the date of surgery to six months after the surgery |
| Device deficiencies |
Inclusion Criteria:
Exclusion Criteria:
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For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.
| 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 |
|---|---|---|---|---|---|---|
| Disposable endoscopic linear cutter stapler | Wujin District | Changzhou | China |
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| the investigation sites will be collected from January 2023 to September 2024. |
| Intraoperative conversion (caused by the stapler and/or cartridge) | Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description. | the investigation sites will be collected from January 2023 to September 2024. |
| Length of hospitalization | Records were collected for the patient's date of surgery and date of discharge . Length of hospitalization(days) = date of discharge - date of surgery | the investigation sites will be collected from January 2023 to September 2024. |
| All-cause re-hospitalization rate (within 6 months) | Re-hospitalization data of patients within 6 months after surgery were collected. Postoperative all-cause re-hospitalization rate = number of all-cause re-hospitalization cases/total cases ×100% | From the date of surgery to six months after the surgery |
Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
| From the date of surgery to six months after the surgery |
| Serious adverse events | Incidence of serious adverse events = Number of serious adverse events/number of enrolled cases ×100% | From the date of surgery to six months after the surgery |