[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559912":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":27,"locations":10,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":10,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"The Royal Wolverhampton Hospitals NHS Trust","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iCount Device",null,"A novel external device which can count the swabs and surgical tampons used during childbirth in an objective and validated manner.",[13],"Procedure: iCount Device",{"label":15,"type":10,"description":16,"interventionNames":10},"User Feedback Survey","Anonymised feedback data will be collected from 20 staff users about the user experience and usability of the device. This will be conducted with an online survey questionnaire designed with advice from ergonomics experts after an extensive literature review of human factors-ergonomics principles and MHRA guidance about conducting medical device usability\n\n5 staff users will be randomly selected from the consent forms to have semi-structured interviews developed in accordance with qualitative research methodology for medical device usability testing and user experience.",[18],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":10},"PROCEDURE","Designed as single use. Intended purpose - To be used to count swabs and tampons after surgery in an objective manner. This is intended to be used in patients during and just after surgery.\n\nThis is a device accessory.",[9],[23],{"name":24,"affiliation":25,"role":26},"Aditi Desai","The Royal Wolverhampton NHS Trust","PRINCIPAL_INVESTIGATOR",[28,32],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","01902695166","aditidesai@nhs.net",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Lorraine Jacques","01902 695065","lorraine.jacques@nhs.net",{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[39],{"name":40,"class":6},"Innovate UK","100559912","prevention-of-retained-items-in-childbirth-environment-and-surgical-sites-100559912",false,"NCT06570304","Prevention of Retained Items iN Childbirth Environment and Surgical Sites","Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study","PRINCESS","Inclusion Criteria:\n\n1. Patients due to undergo surgery at the chosen NHS Trust.\n2. Patients 18 years or older and consented to participation after an informed choice.\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Emergency surgery",true,"FEMALE","18 Years",{"count":53,"type":54},30,"ESTIMATED","OBSERVATIONAL","To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.",[58],"Retained Surgical Items","NOT_YET_RECRUITING","2026-01-13",{"date":62,"type":63},"2026-01-15","ACTUAL",{"date":65,"type":54},"2026-06",{"date":67,"type":54},"2027-06",{"name":5,"class":6}]