[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568214":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":50,"studyPopulation":43,"armGroups":51,"interventions":64,"overallOfficials":74,"centralContacts":79,"locations":84,"responsibleParty":99,"collaborators":43,"id":101,"slug":43,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":43,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":43,"overallStatus":120,"whyStopped":43,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Almaviva Sante","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Efficacy of embolisation","Efficacy of embolisation will be assessed with IPSS score (International Prostate Symptoms Score). IPSS questionnaire consists of 7 questions (ranging from 0 to 5) on mictional difficulties for a maximum total of 35 points (0 means no mictional difficulty).","Month 3",[14,18,21,24,27,30,33,37,39],{"measure":15,"description":16,"timeFrame":17},"Post-Mictional Residue","Post-Mictional Residue will be assessed will be measured in ml by ultrasound","Month 1, Month 3 and Month 12",{"measure":19,"description":20,"timeFrame":12},"Prostatic infarct areas","Prostatic infarct areas will be measured in mm3 on MRI",{"measure":22,"description":23,"timeFrame":17},"Sexual function","Sexual function will be assessed with IIEF5 questionnaire (International Index of Erectile Function form 5) (0 - 25 points). Score lower than 10 means severe erectile dysfunction whereas score higher than 20 means normal erectile function.",{"measure":25,"description":26,"timeFrame":17},"Patient quality of life","Patient quality of life will be assessed with IPSS quality of life question (1 - 7). 1 means patient is very satisfied of his\u002Fher quality of life",{"measure":28,"description":29,"timeFrame":17},"Prostatic Serum Antigen","Prostatic Serum Antigen (PSA) will be measured from blood sample. Normal value should be lower than 4 ng\u002Fml",{"measure":31,"description":32,"timeFrame":17},"Urinary flow","Urinary flow will be measured in ml\u002Fs by flow measurement",{"measure":34,"description":35,"timeFrame":36},"Prostatic volume","Prostatic volume will be in ml on MRI","Month 3 and Month 12",{"measure":10,"description":11,"timeFrame":38},"Month 1 and Month 12",{"measure":40,"description":41,"timeFrame":42},"Safety of embolisation","Safety of embolisation will be assessed with post-empbolisation symptoms description and other adverse events description","Day 15, Month 3 and Month 12",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE","Prostatic artery embolisation (PAE) is an alternative treatment to surgery for benign prostatic hyperplasia (BPH), and its place is recognised in the recommendations of the Male Voiding Disorders Committee (French Urological Association). It has been practised since 2012 (Carnevale et al, 2020), and numerous publications have proved not only its safety but also its efficacy (Malling et al, 2019).\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, used by the majority of expert prostate embolisation teams, 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 (Loffroy et al, 2021). Another retrospective comparative study (Salet et al, 2022) reported no significant difference in clinical efficacy between the use of glue and 300-500 micron trisacryl particles.\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.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Magic Glue®","EXPERIMENTAL","Embolisation of the prostatic arteries will be performed with Magic Glue® combined with lipiodol",[57],"Device: Embolisation with Magic Glue®",{"label":59,"type":60,"description":61,"interventionNames":62},"Embosphere®","ACTIVE_COMPARATOR","Embolisation of prostatic arteries will be performed with 300-500 micron trisacryl particles (Embosphere®)",[63],"Device: Embolisation with Embosphere®",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":43},"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",[53],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"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",[59],[75],{"name":76,"affiliation":77,"role":78},"Grégory AMOUYAL, MD","Clinique de l'Alma","PRINCIPAL_INVESTIGATOR",[80],{"name":76,"role":81,"phone":82,"phoneExt":43,"email":83},"CONTACT","+ 33 6 80 70 40 40","dr.gregory.amouyal@gmail.com",[85],{"facility":77,"status":43,"city":86,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Paris","75007","France","FR",{"type":91,"coordinates":92},"Point",[93,94],2.3488,48.85341,{"lat":94,"lon":93},[97],{"name":76,"role":81,"phone":98,"phoneExt":43,"email":83},"+33 6 80 70 40 40",{"type":100,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","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":112,"type":113},96,"ESTIMATED","INTERVENTIONAL",[116],"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.",[119],"Benign Prostatic Hyperplasia","NOT_YET_RECRUITING","2024-11-06",{"date":123,"type":124},"2024-11-07","ACTUAL",{"date":126,"type":113},"2024-12-01",{"date":128,"type":113},"2027-05-31",{"name":5,"class":6},1]