[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532420":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":19,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":19,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":19,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KeySuite","EXPERIMENTAL","The KeyLoop and KeyScope devices will be used to perform intra-abdominal biopsies.",[13],"Device: KeySuite",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","KeyScope and KeyLoop will be used to perform biopsies of intra-abdominal masses and cancers.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Tamara Fitzgerald, MD, PhD","Duke Health","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","919-681-5077","tamara.fitzgerald@duke.edu",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Dana Giangiacomo","919-684-3821","dana.giangiacomo@duke.edu",[35],{"facility":36,"status":19,"city":37,"state":19,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Uganda Cancer Institute","Kampala","Uganda","UG",{"type":41,"coordinates":42},"Point",[43,44],32.58219,0.31628,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":49,"phoneExt":19,"email":50},"Nixon Niyonzima, PhD","+256 755 677 395","nniyonzima@gmail.com",{"type":52,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[54,56],{"name":55,"class":6},"Makerere University",{"name":36,"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":66,"type":67},12,"ESTIMATED","INTERVENTIONAL",[70],"NA","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.",[73],"Abdominal Neoplasm","NOT_YET_RECRUITING","2026-06-01",{"date":77,"type":78},"2026-06-03","ACTUAL",{"date":80,"type":67},"2026-07-01",{"date":82,"type":67},"2028-06-30",{"name":5,"class":6},1]