[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568214":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Almaviva Sante","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magic Glue®","EXPERIMENTAL","Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol",[13],"Device: Embolisation with Magic Glue®",{"label":15,"type":16,"description":17,"interventionNames":18},"Embosphere®","ACTIVE_COMPARATOR","Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®)",[19],"Device: Embolisation with Embosphere®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Embolisation with Magic Glue®","Magic Glue® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Embolisation with Embosphere®","Embosphere® will be injected within prostatic arteries, leading to ischaemia and necrosis of part of the adenomatous tissue of the prostate gland",[15],[32],{"name":33,"affiliation":34,"role":35},"Grégory AMOUYAL, MD","Clinique de l'Alma","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+ 33 6 80 70 40 40","dr.gregory.amouyal@gmail.com",[42],{"facility":34,"status":26,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Paris","75007","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3488,48.85341,{"lat":51,"lon":50},[54],{"name":33,"role":38,"phone":55,"phoneExt":26,"email":40},"+33 6 80 70 40 40",{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100568214","comparison-of-glue-with-microparticles-in-prostatic-artery-embolization-100568214",false,"NCT06678308","Comparison of Glue with Microparticles in Prostatic Artery Embolization","Comparison of the Efficacy and Safety of Glue with Calibrated Microparticles in Prostatic Artery Embolisation As a Treatment for Symptomatic Benign Prostatic Hyperplasia.","EMBOLICOL","Inclusion Criteria:\n\n* Male patient aged ≥ 50 years and ≤ 80 years\n* Patient with symptomatic BPH (prostatic volume ≥ 40 ml measured on prostatic MRI, IPSS ≥ 8, uroflowmetry \\\u003C 15 ml\u002Fs).\n* Patient failing or intolerant to drug treatment (tadalafil and\u002For one of the alpha-blockers, alfuzosin, tamsulosin, silodosin or doxazosin).\n\nExclusion Criteria:\n\n* Patient with advanced and complicated BPH on renal and bladder ultrasound:\n\nSevere obstruction related bladder wall lesions : \\>3 micro-diverticula or single or multiple diverticula with a sac diameter \\> 10 mm.\n\nChronic dilatation of the excretory cavities : diameter of one or both pyelons \\>15 mm.\n\n* Patient with suspected prostate or bladder cancer on MRI\n* Patients with moderate or severe chronic renal failure, with creatinine clearance \\\u003C 40 ml\u002Fmin.\n* Patient with prostate or bladder cancer diagnosed by biopsy in the 6 months preceding the inclusion visit.\n* Patient with an active urinary tract infection\n* Patient already included and participating in another clinical study.","MALE","50 Years","80 Years",{"count":70,"type":71},96,"ESTIMATED","INTERVENTIONAL",[74],"NA","Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH). It has been practised since 2012 and numerous publications have proved not only its safety but also its efficacy.\n\nThe principle of PAE is to occlude the prostatic arteries with an 'embolising agent', which will result in ischaemia and necrosis of part of the adenomatous tissue of the prostate.\n\nThe reference embolisation agent is a suspension of calibrated trisacryl microparticles 300-500 microns in size.\n\nRecently, the use of glue has been retrospectively studied with acceptable efficacy and safety.\n\nIn this context, where only the results of retrospective studies are available, it is necessary to initiate comparative prospective studies to assess the efficacy and safety of the glue compared with calibrated microparticles.",[77],"Benign Prostatic Hyperplasia","NOT_YET_RECRUITING","2024-11-06",{"date":81,"type":82},"2024-11-07","ACTUAL",{"date":84,"type":71},"2024-12-01",{"date":86,"type":71},"2027-05-31",{"name":5,"class":6},1]