[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381952":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":69,"collaborators":19,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":19,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":19,"enrollmentInfo":79,"targetDuration":19,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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",[27,46,56],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Hollywood Private Hospital","RECRUITING","Nedlands","Western Australia","6009","Australia","AU",{"type":36,"coordinates":37},"Point",[38,39],115.8073,-31.98184,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Krys Hiscock, RN","0474 769 593","nursing@affinityresearch.com.au",{"facility":47,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"Sir Charles Gairdner Hospital",{"type":36,"coordinates":49},[38,39],{"lat":39,"lon":38},[52],{"name":53,"role":23,"phone":54,"phoneExt":19,"email":55},"Shirley Jansen, MD","+61 8 6151 0820","JShirley.Jansen@health.wa.gov.au",{"facility":57,"status":29,"city":58,"state":19,"zip":19,"country":33,"countryCode":34,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Flinders","Adelaide",{"type":36,"coordinates":60},[61,62],138.59863,-34.92866,{"lat":62,"lon":61},[65],{"name":66,"role":23,"phone":67,"phoneExt":19,"email":68},"Melanie Toomey","08 82045445","Melanie.Toomey@sa.gov.au",{"type":70,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100381952","feasibility-of-the-innovein-valve-and-delivery-system-for-chronic-venous-insufficiency-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":80,"type":81},5,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87],"Chronic Venous Insufficiency","2021-09-15",{"date":90,"type":91},"2021-09-17","ACTUAL",{"date":93,"type":91},"2020-01-15",{"date":95,"type":81},"2027-01-15",{"name":5,"class":6},3]