About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
use the study device during surgery
Disqualifiers
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;
combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.
Trial population
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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Disposable endoscope linear cutting stapler and components
Deviceto use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.
Treatment groups
Trial outcomes
Primary outcomes
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%
Sponsors and contacts
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Suzhou Care-Real Medical Technology Co., Ltd.
Lead sponsor
Jiangsu Channel Medical Device Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: