[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intravenous-access\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intravenous-access":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100571975",false,"NCT06727240","Safe-Infusion Study","A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters","Inclusion Criteria:\n\n* The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \\\u003C2h.\n* ≥18 years of age\n* Speak and understand local language\n* VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion\n* Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent\n\nExclusion Criteria:\n\n* The VAD is expected to be used for sampling only\n* Pregnancy\n* Unable to obtain informed consent or without an available LAR to provide surrogate informed consent\n* Patients under palliative care\n* Bolus IV infusion, defined as an infusion time of \\\u003C15 min","ALL","18 Years",{"count":18,"type":19},548,"ESTIMATED","INTERVENTIONAL",[22],"NA","Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.",[25,26],"Intravenous Access","Medical Device","RECRUITING","2024-12-11",{"date":30,"type":31},"2024-12-16","ACTUAL",{"date":33,"type":31},"2024-03-25",{"date":35,"type":19},"2025-03",{"name":37,"class":38},"Interlinked AB","INDUSTRY",2,""]