[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589100":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":86,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Sirius Medical Systems B.V.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary breast lesion and\u002For axillary lymph node localisation prior to surgical excision","EXPERIMENTAL","Device: CANOPUS Magnetic Marker by Sirius Medical Systems B.V.\n\nPlacement of experimental device in primary breast lesion and\u002For axillary lymph node indicated for surgical removal and requiring localisation",[13],"Device: Magnetic seed",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Magnetic seed","All patients enrolled will receive a single Sirius Canopus Marker with two anchors added to it for improved tissue fixation. Implantation will be done by a radiologist before breast conserving surgery, usually scheduled within a few days after Canopus Marker implantation. The Canopus Marker is removed with the specimen during the surgery.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Bram Schermers, CEO\u002FCTO","CONTACT","+31 6 48044508","bram.schermers@sirius-medical.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Kitty Kempen Kempen, PhD, Clinical Affairs Director","+31 6 10223238","kitty.kempen@sirius-medical.com",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Rode Kruis Ziekenhuis","Beverwijk","North Holland","1942 LE","Netherlands","NL",{"type":40,"coordinates":41},"Point",[42,43],4.65694,52.48333,{"lat":43,"lon":42},[46,48,51],{"name":47,"role":24,"phone":20,"phoneExt":20,"email":20},"Carlinda Bresser, Research Coordinator",{"name":49,"role":50,"phone":20,"phoneExt":20,"email":20},"Niels Harlaar, Surgeon","PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Gisela Moormann, Surgeon","SUB_INVESTIGATOR",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":6},"Avania","100589100","safety--performance-of-canopus-pintuition-surgical-marker-navigation-100589100",false,"NCT06950021","Safety & Performance of CANOpus PINtuition Surgical Marker Navigation","Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)","CANOPIN","Inclusion Criteria:\n\n1. Subject is willing and able to provide informed consent for the investigation\n2. Subject is at least 18 years of age\n3. Subject is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive)\n4. Tumour is ultrasound visible\n5. Subject is indicated for primary breast conserving surgery and\u002For targeted axillary dissection\n6. Subject is indicated for preoperative localization using a single marker in the primary breast lesion and\u002For a single marker in an axillary lymph node\n\nExclusion Criteria:\n\n1. Subject is lactating or pregnant\n2. Subject is expected to have surgery scheduled more than 6 weeks after implantation of the Canopus Marker.\n3. Subject has an ICD or other active implant such as a pacemaker less than 5 cm away from the intended target location(s)\n4. Subject has a proven infection or clinically significant hematoma at or close to the intended target location(s)\n5. Subject is expected to require an MRI scan in the period between implantation and surgery\n6. Known hypersensitivity to Titanium or Nickel","ALL","18 Years",{"count":70,"type":71},35,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are:\n\n1. Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal?\n2. What is the satisfaction level of radiologists, surgeons, and patients with the use of the Canopus Marker?\n\nParticipants will:\n\n* Have the Canopus Marker implanted into the tumor or nearby tissue using ultrasound guidance.\n* Undergo surgery where the Canopus Marker will help guide the surgeon to the tumor, and the marker will be removed along with the tumor. This surgery is performed using an FDA cleared and CE-marked detection device (Sirius Pintuition Detector).\n* Attend a follow-up visit two weeks after surgery to assess any adverse events and overall satisfaction.",[77,78],"Breast Surgery","Lymph Node Excision",[80,81,82,83,84,85],"Breast conserving surgery","magnetic seed localization","pintuition","breast sparing surgery","surgical localization","surgical navigation","NOT_YET_RECRUITING","2025-04-22",{"date":89,"type":90},"2025-04-29","ACTUAL",{"date":92,"type":71},"2025-07-01",{"date":94,"type":71},"2026-02-01",{"name":5,"class":6},1]