[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532420":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":37,"armGroups":41,"interventions":48,"overallOfficials":53,"centralContacts":58,"locations":67,"responsibleParty":84,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":37,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":37,"maxAge":37,"enrollmentInfo":98,"targetDuration":37,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":37,"overallStatus":106,"whyStopped":37,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Establish the clinical safety KeySuite","This will be determined by whether or not the procedure was able to be completed laproscopically or had to be converted to open surgery.","Day of surgery",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Time to complete surgery","Length of surgery will be recorded",{"measure":18,"description":19,"timeFrame":12},"Estimated blood loss","Blood loss will be recorded",{"measure":21,"description":22,"timeFrame":12},"Surgical injuries and adverse events","Surgical injuries (device-related and unrelated) and other adverse events at the time of surgery will be recorded",[24,28,31],{"measure":25,"description":26,"timeFrame":27},"Surgical site infection","Any infections at the surgical site will be recorded and followed until resolution","30 days",{"measure":29,"description":30,"timeFrame":27},"Post-operative complications","All post-operative complications will be recorded",{"measure":32,"description":33,"timeFrame":27},"Mortality","Survival through 30 days",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":37,"timePerspective":37,"maskingInfo":39},"NA","SINGLE_GROUP",null,"DIAGNOSTIC",{"masking":40,"maskingDescription":37,"whoMasked":37},"NONE",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"KeySuite","EXPERIMENTAL","The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.",[47],"Device: KeySuite",[49],{"type":50,"name":43,"description":51,"armGroupLabels":52,"otherNames":37},"DEVICE","KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.",[43],[54],{"name":55,"affiliation":56,"role":57},"Tamara Fitzgerald, MD, PhD","Duke Health","PRINCIPAL_INVESTIGATOR",[59,63],{"name":55,"role":60,"phone":61,"phoneExt":37,"email":62},"CONTACT","919-681-5077","tamara.fitzgerald@duke.edu",{"name":64,"role":60,"phone":65,"phoneExt":37,"email":66},"Dana Giangiacomo","919-684-3821","dana.giangiacomo@duke.edu",[68],{"facility":69,"status":37,"city":70,"state":37,"zip":37,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Uganda Cancer Institute","Kampala","Uganda","UG",{"type":74,"coordinates":75},"Point",[76,77],32.58219,0.31628,{"lat":77,"lon":76},[80],{"name":81,"role":60,"phone":82,"phoneExt":37,"email":83},"Nixon Niyonzima, PhD","+256 755 677 395","nniyonzima@gmail.com",{"type":85,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[87,89],{"name":88,"class":6},"Makerere University",{"name":69,"class":6},"100532420","keyscope-study-in-uganda-100532420",false,"NCT06212570","KeyScope Study in Uganda","KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda","Inclusion Criteria:\n\n* diagnosis of intra-abdominal mass suspicious for cancer\n* body mass index (BMI) of 18-30\n* weight 20-100kg\n* biopsy necessary to determine cancer diagnosis and classify pathology\n* surgeon determine that laproscopic biopsy it technically appropriate\n\nExclusion Criteria:\n\n* significant comorbidities\n* previous major abdominal surgery\n* current pregnancy","ALL",{"count":99,"type":100},12,"ESTIMATED","INTERVENTIONAL",[35],"KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.\n\nThe investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.",[105],"Abdominal Neoplasm","NOT_YET_RECRUITING","2026-08-04",{"date":109,"type":110},"2026-08-06","ACTUAL",{"date":112,"type":100},"2026-09-01",{"date":114,"type":100},"2028-06-30",{"name":5,"class":6},1]