[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648030":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":54,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":20,"maxAge":71,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric laparoscopy","EXPERIMENTAL","Pediatric population, planned for intraperitoneal laparoscopic surgery.",[13],"Device: Turbine-based insufflator",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Turbine-based insufflator","Use of the tubine-based insufflator during surgical procedure.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"J. Vlot","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"A.I. Jong","CONTACT","+31107037641","a.i.dejong@erasmusmc.nl",{"name":23,"role":28,"phone":32,"phoneExt":20,"email":20},"+31107039568",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Erasmus MC, University Medical Center Rotterdam","RECRUITING","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],4.47917,51.9225,{"lat":46,"lon":45},[49],{"name":23,"role":28,"phone":32,"phoneExt":20,"email":50},"john.vlot@erasmusmc.nl",{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Ass. Prof. J (John) Vlot MD, PhD, FEBPS","Consultant pediatric surgeon",[55,58,60],{"name":56,"class":57},"Politecnico di Milano University","UNKNOWN",{"name":59,"class":57},"Health∼Holland, Topsector Life Sciences & Health",{"name":61,"class":57},"Spatium Medical B.V.","100648030","the-turbine-based-co2-insufflator-pediatric-feasibility-study-100648030",false,"NCT07715968","The Turbine-based CO2 Insufflator Pediatric Feasibility Study","The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial","TuBa","Inclusion Criteria:\n\n* Weight ≥ 10 kilograms (kg);\n* Laparoscopic procedure;\n* Intraperitoneal procedure;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Inability to use the study-specific trocar during the procedure (surgeon's assessment);\n* The expected time for abdominal insufflation is less than 20 minutes;\n* Conversion to open surgery within 10 minutes after study measurements;\n* Pregnancy.","ALL","18 Years",{"count":73,"type":74},12,"ESTIMATED","INTERVENTIONAL",[77],"NA","A novel CO2 insufflator, the turbine-based insufflator, has been developed to improve minimal invasive surgery. Turbine technology permits accurate pressure control resulting in an intra-abdominal volume that is dynamically adapted to ventilation. In addition, oscillometric measurements are performed to measure the abdominal compliance of the patient. This feasibility trial primarly aims to evaluate the technologic feasibility during pediatric laparoscopic surgery. Secondary outcomes are pressure stability, comparison of intra-abdominal pressure stability between the standard CO2 insufflator and turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.",[80,81],"Laparoscopy","Pneumoperitoneum",[81,83,84,80],"Device development","Insufflator","2026-07-20",{"date":87,"type":88},"2026-07-21","ACTUAL",{"date":90,"type":88},"2026-02-10",{"date":92,"type":74},"2026-12-31",{"name":5,"class":6},1]