[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07525518":3,"trial-entities:NCT07525518":98,"trial-summary:NCT07525518":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":58,"locations":61,"central_contacts":94,"overall_officials":95,"references":96,"see_also_links":97},"NCT07525518","25-01","Okami Medical ALPHA Registry","Okami Medical Comprehensive Registry Platform","ENROLLING_BY_INVITATION","2030-08","2026-07","2026-07-21","2026-03-31","Okami Medical, Inc.","INDUSTRY",false,"This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.",null,[19,20,21,22],"Arterial Bleed","Pulmonary Arteriovenous Malformation","Embolization","Hemorrhage",[],"OBSERVATIONAL",[],{"count":27,"type":28},500,"ESTIMATED",[30],{"type":31,"name":32,"description":32,"armGroupLabels":33},"DEVICE","LOBO Vascular Occlusion System",[34,35,36],"Analysis Population 1","Analysis Population 2","Analysis Population 3",[38,42],{"measure":39,"description":40,"timeFrame":41},"Safety Endpoint","Incidence of device-related serious adverse events during the index procedure","30 days post-index procedure",{"measure":43,"description":44,"timeFrame":45},"Effectiveness Endpoint","Technical success of the LOBO Vascular Occlusion System defined as occlusion of the intended target(s) with the LOBO occluder, assessed by angiography","During index procedure",[],"ALL","18 Years",{"inclusion":50,"exclusion":54,"raw_text":57},[51,52,53],"The patient or their legally authorized representative is willing and able to provide informed consent per local requirements","Has or will receive treatment with an eligible Okami Medical device","Age ≥ 18 years",[55,56],"Is or will be inaccessible for registry follow-up","Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator","Inclusion Criteria:\n\n* The patient or their legally authorized representative is willing and able to provide informed consent per local requirements\n* Has or will receive treatment with an eligible Okami Medical device\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Is or will be inaccessible for registry follow-up\n* Meets exclusion criteria required by local requirements\n* Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator",[59,60],"ADULT","OLDER_ADULT",[62,71,79,87],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"University of Colorado","Aurora","Colorado","80045","United States",{"lat":69,"lon":70},39.72943,-104.83192,{"facility":72,"city":73,"state":74,"zip":75,"country":67,"geoPoint":76},"UMASS Chan Medical School","Worcester","Massachusetts","01655",{"lat":77,"lon":78},42.26259,-71.80229,{"facility":80,"city":81,"state":82,"zip":83,"country":67,"geoPoint":84},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"lat":85,"lon":86},35.9132,-79.05584,{"facility":88,"city":89,"state":82,"zip":90,"country":67,"geoPoint":91},"Charlotte Radiology","Charlotte","28202",{"lat":92,"lon":93},35.22709,-80.84313,[],[],[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[22,100],"Pulmonary arteriovenous malformation",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]