[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568114":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":10,"maxAge":10,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},{"fullName":5,"class":6},"Suzhou Care-Real Medical Technology Co., Ltd.","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Disposable endoscopic linear cutter stapler",null,[12],"Device: Disposable endoscopic linear cutter stapler",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"DEVICE","Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Ke Zhou","CONTACT","+86 18118447767","ke.zhou@care-real.com",[25],{"facility":9,"status":10,"city":26,"state":27,"zip":10,"country":28,"countryCode":29,"cosmosGeoPoint":10,"geoPoint":10,"contacts":30},"Wujin District","Changzhou","China","CN",[31],{"name":32,"role":21,"phone":33,"phoneExt":10,"email":34},"Xiaohong Xu","+86 13915015530","xuxiaohong@czakyl.com",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100568114","post-market-clinical-follow-up-study-plan-for-disposable-endoscopic-linear-cutter-stapler-100568114",false,"NCT06677008","Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler","Inclusion Criteria:\n\n* Age unlimited and gender unlimited;\n* The surgery type shall be endoscopic surgery;\n* The departments of surgical procedures: general and thoracic surgical procedures;\n* Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.\n\nExclusion Criteria:\n\n* Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;\n* Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;\n* Surgery record is incomplete, unable to extract main indicators related information.","ALL",{"count":45,"type":46},302,"ESTIMATED","OBSERVATIONAL","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.",[50],"The Expeditious Transection\u002Fresection of Tissues and Creation of Anastomoses","NOT_YET_RECRUITING","2024-11-04",{"date":54,"type":55},"2024-11-06","ACTUAL",{"date":57,"type":46},"2024-11-15",{"date":59,"type":46},"2025-02-28",{"name":5,"class":6},1]