[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378979":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":41,"responsibleParty":56,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":10,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"baseline assessment group",null,"n=150 patiënts for baseline assessment",[13],"Diagnostic Test: tissue and blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"clinical need for reintervention group","n=20-30 patiënts for re-bronchoscopy",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"clinical stable controls","n=20 stable treated control patiënts",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","tissue and blood sampling","only diagnostics will be peformed",[9,15,19],[29],{"name":30,"affiliation":31,"role":32},"Dirk-Jan Slebos, MD PhD","UMC-Groningen\u002FNL","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","+31503616161","d.j.slebos@umcg.nl",{"name":39,"role":35,"phone":10,"phoneExt":10,"email":40},"Jorine Hartman, PhD","j.hartman@umcg.nl",[42],{"facility":5,"status":43,"city":44,"state":10,"zip":10,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Groningen","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],6.56667,53.21917,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":10,"phoneExt":10,"email":10},"Dirk-Jan Slebos, PhD",{"type":32,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dirk-Jan Slebos","Prof. dr. D.J. Slebos MD, PhD, Principle Investigator","100378979","biological-investigation-of-explanted-endobronchial-lung-valves-study-100378979",false,"NCT04214587","Biological Investigation of Explanted Endobronchial Lung Valves Study","Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions","Bio-EXCEL","Inclusion Criteria:\n\n* Elidgible for EBV treatment\n\nExclusion Criteria:\n\n* Anticoagulation which cannot be stopped prior to the procedure","ALL",{"count":69,"type":70},150,"ESTIMATED","OBSERVATIONAL","Rationale:\n\nCOPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone\u002Fnitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.\n\nObjective:\n\nThe main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.",[74],"Emphysema or COPD","2024-06-13",{"date":77,"type":78},"2024-06-14","ACTUAL",{"date":80,"type":78},"2021-03-16",{"date":82,"type":70},"2027-03-02",{"name":5,"class":6},1]