[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568114":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":42,"studyPopulation":45,"armGroups":46,"interventions":51,"overallOfficials":42,"centralContacts":56,"locations":62,"responsibleParty":73,"collaborators":42,"id":75,"slug":42,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":42,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":42,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":42,"briefSummary":85,"conditions":86,"keywords":42,"overallStatus":88,"whyStopped":42,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Suzhou Care-Real Medical Technology Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Operation time","Confirmed by surgical records and anesthesia sheets.","The investigation sites will be collected from January 2023 to September 2024.",{"measure":19,"description":20,"timeFrame":12},"Amount of intraoperative blood loss","Confirmed by surgical records\u002Fnursing notes.",{"measure":22,"description":23,"timeFrame":12},"Intraoperative conversion (caused by the stapler and\u002For cartridge)","Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description.",{"measure":25,"description":26,"timeFrame":12},"Length of hospitalization","Records were collected for the patient's date of surgery and date of discharge .\n\nLength of hospitalization(days) = date of discharge - date of surgery",{"measure":28,"description":29,"timeFrame":30},"All-cause re-hospitalization rate (within 6 months)","Re-hospitalization data of patients within 6 months after surgery were collected.\n\nPostoperative all-cause re-hospitalization rate = number of all-cause re-hospitalization cases\u002Ftotal cases ×100%","From the date of surgery to six months after the surgery",[32,35,38],{"measure":33,"description":34,"timeFrame":30},"Adverse events","Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc.",{"measure":36,"description":37,"timeFrame":30},"Device deficiencies","Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.",{"measure":39,"description":40,"timeFrame":30},"Serious adverse events","Incidence of serious adverse events = Number of serious adverse events\u002Fnumber of enrolled cases ×100%",{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":43,"timePerspective":44,"maskingInfo":42},null,"COHORT","RETROSPECTIVE","For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection\u002Fresection of tissues and creation of anastomoses.",[47],{"label":48,"type":42,"description":42,"interventionNames":49},"Disposable endoscopic linear cutter stapler",[50],"Device: Disposable endoscopic linear cutter stapler",[52],{"type":53,"name":48,"description":54,"armGroupLabels":55,"otherNames":42},"DEVICE","Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)",[48],[57],{"name":58,"role":59,"phone":60,"phoneExt":42,"email":61},"Ke Zhou","CONTACT","+86 18118447767","ke.zhou@care-real.com",[63],{"facility":48,"status":42,"city":64,"state":65,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":42,"geoPoint":42,"contacts":68},"Wujin District","Changzhou","China","CN",[69],{"name":70,"role":59,"phone":71,"phoneExt":42,"email":72},"Xiaohong Xu","+86 13915015530","xuxiaohong@czakyl.com",{"type":74,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":82,"type":83},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.",[87],"The Expeditious Transection\u002Fresection of Tissues and Creation of Anastomoses","NOT_YET_RECRUITING","2024-11-04",{"date":91,"type":92},"2024-11-06","ACTUAL",{"date":94,"type":83},"2024-11-15",{"date":96,"type":83},"2025-02-28",{"name":5,"class":6},1]