[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400392":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":23,"responsibleParty":120,"collaborators":7,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":136,"studyType":137,"phases":7,"briefSummary":138,"conditions":139,"keywords":148,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"OncoSil Medical Limited","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Paul J Ross, MRCP, MBBS","Guy's and St Thomas' NHS Foundation Trust, London, UK","PRINCIPAL_INVESTIGATOR",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Tom Maher","CONTACT","+44 750 4658585","tom.maher@oncosil.com",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Nicole G Gaddi, B.Sc Nursing","+ 61 (0)428 946 588","nicole.gaddi@oncosil.com",[24,39,51,60,69,77,88,99,112],{"facility":25,"status":26,"city":27,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Complejo Hospitalario Universitario Insular Materno-Infantil","RECRUITING","Las Palmas de Gran Canaria","Spain","ES",{"type":31,"coordinates":32},"Point",[33,34],-15.41573,28.10178,{"lat":34,"lon":33},[37],{"name":38,"role":16,"phone":7,"phoneExt":7,"email":7},"Fayna Armas, MD",{"facility":40,"status":26,"city":41,"state":7,"zip":42,"country":28,"countryCode":29,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Hospital Universitario Ramón y Cajal","Madrid","28034",{"type":31,"coordinates":44},[45,46],-3.70256,40.4165,{"lat":46,"lon":45},[49],{"name":50,"role":16,"phone":7,"phoneExt":7,"email":7},"Ana Garcia, MD",{"facility":52,"status":26,"city":41,"state":7,"zip":53,"country":28,"countryCode":29,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Hospital Universitario de Fuenlabrada","28942",{"type":31,"coordinates":55},[45,46],{"lat":46,"lon":45},[58],{"name":59,"role":16,"phone":7,"phoneExt":7,"email":7},"Fernando Pereira, MD",{"facility":61,"status":62,"city":41,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Hospital Universitario Doce De Octobre","NOT_YET_RECRUITING",{"type":31,"coordinates":64},[45,46],{"lat":46,"lon":45},[67],{"name":68,"role":16,"phone":7,"phoneExt":7,"email":7},"Maria J Tabuenca, MD",{"facility":70,"status":62,"city":41,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Hospital Universitario La Paz",{"type":31,"coordinates":72},[45,46],{"lat":46,"lon":45},[75],{"name":76,"role":16,"phone":7,"phoneExt":7,"email":7},"Eva Martin, MD",{"facility":78,"status":26,"city":79,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Clinica Universidad De Navarra","Pamplona",{"type":31,"coordinates":81},[82,83],-1.64323,42.81687,{"lat":83,"lon":82},[86],{"name":87,"role":16,"phone":7,"phoneExt":7,"email":7},"Maria M Rodriguez, MD",{"facility":89,"status":26,"city":90,"state":7,"zip":7,"country":28,"countryCode":29,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hospital Clinico Universitario De Valladolid","Valladolid",{"type":31,"coordinates":92},[93,94],-4.72353,41.65541,{"lat":94,"lon":93},[97],{"name":98,"role":16,"phone":7,"phoneExt":7,"email":7},"Purificacion Rodriguez, MD",{"facility":100,"status":62,"city":101,"state":7,"zip":7,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hammersmith Hospital","London","United Kingdom","UK",{"type":31,"coordinates":105},[106,107],-0.12574,51.50853,{"lat":107,"lon":106},[110],{"name":111,"role":16,"phone":7,"phoneExt":7,"email":7},"Harpreet Wasan, MD",{"facility":113,"status":62,"city":101,"state":7,"zip":7,"country":102,"countryCode":103,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"The London Clinic",{"type":31,"coordinates":115},[106,107],{"lat":107,"lon":106},[118],{"name":119,"role":16,"phone":7,"phoneExt":7,"email":7},"Zarni Win",{"type":121,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100400392","osprey-is-a-post-market-global-multicentre-observational-prospective-registry-100400392",false,"NCT04493632","OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.","OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)","OSPREY","Inclusion Criteria:\n\n1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).\n2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.\n3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.\n4. Pancreatic target tumour recommended size of \\\u003C7 cm (longest diameter) and \\\u003C110 cc volume.\n5. A clinically acceptable ECOG performance status.\n6. Patients ≥ 18 years of age at screening.\n7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.\n8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.\n\nExclusion Criteria:\n\n1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.\n2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).\n3. Evidence of distant metastases based on review of baseline CT scan.\n4. More than one primary lesion.\n5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:\n\n   * where previous EUS-FNA was considered technically too difficult to perform;\n   * imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;\n   * presence (or significant risk) of varices near to the target tumour.\n6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).\n7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.\n8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.\n9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components","ALL","18 Years","90 Years",{"count":134,"type":135},500,"ESTIMATED","24 Months","OBSERVATIONAL","The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.\n\nThe Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.",[140,141,142,143,144,145,146,147],"Pancreatic Neoplasm","Digestive System Neoplasm","Neoplasms by Site","Neoplasms","Endocrine Gland Neoplasm","Digestive System Disease","Pancreatic Diseases","Endocrine System Diseases",[149,150,151,152,153,154,155,156,157,158,159,160,161,162,163],"Pancreatic Cancer","Pancreas","Metastases","Pancreatic tumor","Unresectable","Locally advanced","Implantable","Radiographic","Device","Phosphorous-32","OncoSil™","Brachytherapy","Gemcitabine","Nab-paclitaxel","Abraxane","2024-04-29",{"date":166,"type":167},"2024-04-30","ACTUAL",{"date":169,"type":167},"2022-04-12",{"date":171,"type":135},"2027-10-01",{"name":5,"class":6},9]