[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381952":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":68,"collaborators":19,"id":70,"slug":19,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":19,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":19,"enrollmentInfo":77,"targetDuration":19,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"InnoVein","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Subjects will have the InnoVein Valve implanted",[13],"Device: InnoVein Valve Treatment",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DEVICE","InnoVein Valve Treatment",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"InnoVen Data Management","CONTACT","650-302-0847","IM-CP-2001@innoveinmedical.com",[27,45,55],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hollywood Private Hospital","RECRUITING","Nedlands","Western Australia","6009","Australia",{"type":35,"coordinates":36},"Point",[37,38],115.8073,-31.98184,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Krys Hiscock, RN","0474 769 593","nursing@affinityresearch.com.au",{"facility":46,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"Sir Charles Gairdner Hospital",{"type":35,"coordinates":48},[37,38],{"lat":38,"lon":37},[51],{"name":52,"role":23,"phone":53,"phoneExt":19,"email":54},"Shirley Jansen, MD","+61 8 6151 0820","JShirley.Jansen@health.wa.gov.au",{"facility":56,"status":29,"city":57,"state":19,"zip":19,"country":33,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Flinders","Adelaide",{"type":35,"coordinates":59},[60,61],138.59863,-34.92866,{"lat":61,"lon":60},[64],{"name":65,"role":23,"phone":66,"phoneExt":19,"email":67},"Melanie Toomey","08 82045445","Melanie.Toomey@sa.gov.au",{"type":69,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100381952",false,"NCT04253301","Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency","Key Inclusion Criteria:\n\n* Willing and able to provide written Informed Consent\n* Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein\n* Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication\n* Life expectancy \\>1yr\n* Reflux time \\>1s in the superficial femoral and\u002For popliteal vein\n\nKey Exclusion Criteria:\n\n* Any prior deep vein intervention within 6 months prior to the Index Procedure\n* History of 2+ DVTs\n* Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC\n* Current IVC Placement\n* History of pulmonary embolism within 6 months\n* Conditions that increase the risk of device thrombosis or patient bleeding\n* Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure\n* Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol","ALL","18 Years",{"count":78,"type":79},5,"ESTIMATED","INTERVENTIONAL",[82],"NA","This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.",[85],"Chronic Venous Insufficiency","2021-09-15",{"date":88,"type":89},"2021-09-17","ACTUAL",{"date":91,"type":89},"2020-01-15",{"date":93,"type":79},"2027-01-15",{"name":5,"class":6},3]