Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components (NCT06555276) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
China195 participantsStarted 2024-08-20
Plain-language summary
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.
Who can participate
SexALL
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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.
* use the study device during surgery
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;
* combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; â‘¢ surgical records are incomplete, and information related to major indicators cannot be extracted; â‘£ other situations that the researcher considers inappropriate for inclusion in the study.
What they're measuring
1
anastomosis success rate
Timeframe: within six months after surgery
Trial details
NCT IDNCT06555276
SponsorSuzhou Care-Real Medical Technology Co., Ltd.