[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100324660":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":229,"collaborators":25,"id":231,"slug":232,"hasResults":233,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":233,"sex":238,"minAge":239,"maxAge":25,"enrollmentInfo":240,"targetDuration":25,"studyType":243,"phases":244,"briefSummary":246,"conditions":247,"keywords":251,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Alphapump","EXPERIMENTAL","Alfapump® device implantation under general anesthesia (30-45 minutes)",[13],"Device: Alphapump",{"label":15,"type":16,"description":17,"interventionNames":18},"Ascites puncture","ACTIVE_COMPARATOR","Iterative paracentesis compensated for by albumin infusions in ambulatory care.",[19],"Procedure: Ascites puncture",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Alfapump® device: a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder where they are eliminated by the urinary tract.\n\nMedical device marked CE, used in the indication provided for marking",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Hospitalizations for evacuating ascites are performed at least twice a month and can be up to 2 times a week. A clinical and biological examination is carried out at each visit.",[15],[31],{"name":32,"affiliation":5,"role":33},"Marie-Noelle HILLERET, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Sandra DAVID-TCHOUDA, MD","CONTACT","+33 476 76 71 86","sdavidtchouda@chu-grenoble.fr",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Sandrine MASSICOT","+33 476 76 88 60","smassicot@chu-grenoble.fr",[45,71,90,109,127,146,159,176,192,213],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Amiens-Picardie University Hospital","RECRUITING","Amiens","80000","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.3,49.9,{"lat":56,"lon":55},[59,62,66,68],{"name":60,"role":37,"phone":25,"phoneExt":25,"email":61},"Eric NGUYEN-KHAC, MDPhD","Nguyen-Khac.Eric@chu-amiens.fr",{"name":63,"role":37,"phone":64,"phoneExt":25,"email":65},"Rachida FAHEM","+333 22 08 88 67","fahem.rachida@chu-amiens.fr",{"name":67,"role":33,"phone":25,"phoneExt":25,"email":25},"Eric NGUYEN-KHAC, MDPHD",{"name":69,"role":70,"phone":25,"phoneExt":25,"email":25},"Jean-Marc REGIMBEAU, MDPHD","SUB_INVESTIGATOR",{"facility":72,"status":47,"city":73,"state":25,"zip":74,"country":50,"countryCode":51,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Chu Angers","Angers","49000",{"type":53,"coordinates":76},[77,78],-0.55202,47.47156,{"lat":78,"lon":77},[81,84,87,88],{"name":82,"role":37,"phone":25,"phoneExt":25,"email":83},"Frédéric OBERTI, MD PHD","foberti@chu-angers.fr",{"name":85,"role":37,"phone":25,"phoneExt":25,"email":86},"Pierre CELEA","pierre.celea@chu-angers.fr",{"name":82,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":89,"role":70,"phone":25,"phoneExt":25,"email":25},"Emilie LERMITE, MD",{"facility":91,"status":47,"city":92,"state":25,"zip":93,"country":50,"countryCode":51,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Jean MINJOZ Univesity Hospital","Besançon","25000",{"type":53,"coordinates":95},[96,97],6.01815,47.24878,{"lat":97,"lon":96},[100,103,107],{"name":101,"role":37,"phone":25,"phoneExt":25,"email":102},"Thierry THEVENOT, MDPhD","tthevenot@chu-besancon.fr",{"name":104,"role":37,"phone":105,"phoneExt":25,"email":106},"Emilie MUEL","+333 81 66 84 96","emuel@chu-besancon.fr",{"name":108,"role":33,"phone":25,"phoneExt":25,"email":25},"Thierry THEVENOT, MDPHD",{"facility":110,"status":111,"city":112,"state":25,"zip":113,"country":50,"countryCode":51,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Haut-Lévêque Hospital","NOT_YET_RECRUITING","Bordeaux","33000",{"type":53,"coordinates":115},[116,117],-0.58046,44.84124,{"lat":117,"lon":116},[120,123],{"name":121,"role":37,"phone":25,"phoneExt":25,"email":122},"Victor DE LEDINGHEN, MD PhD","victor.deledinghen@chu-bordeaux.fr",{"name":124,"role":37,"phone":125,"phoneExt":25,"email":126},"Maude CHARBONNIER","+335 57 65 63 11","maude.charbonnier@chu-bordeaux.fr",{"facility":128,"status":47,"city":129,"state":25,"zip":130,"country":50,"countryCode":51,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Beaujon Hospital","Clichy","92110",{"type":53,"coordinates":132},[133,134],2.30952,48.90018,{"lat":134,"lon":133},[137,140,144],{"name":138,"role":37,"phone":25,"phoneExt":25,"email":139},"Claire FRANCOZ, MD","claire.francoz@aphp.fr",{"name":141,"role":37,"phone":142,"phoneExt":25,"email":143},"Vanessa ESNAULT","+33 140 87 50 64","vanessa.esnault@aphp.fr",{"name":145,"role":33,"phone":25,"phoneExt":25,"email":25},"Claire FRANCOZ",{"facility":147,"status":47,"city":148,"state":25,"zip":149,"country":50,"countryCode":51,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Grenoble University Hospital","Grenoble","38000",{"type":53,"coordinates":151},[152,153],5.71479,45.17869,{"lat":153,"lon":152},[156],{"name":32,"role":37,"phone":157,"phoneExt":25,"email":158},"+334 76 76 62 57","mnhilleret@chu-grenoble.fr",{"facility":160,"status":47,"city":161,"state":25,"zip":162,"country":50,"countryCode":51,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"LA PITIE SALPETRIERE Univesity Hospital","Paris","75013",{"type":53,"coordinates":164},[165,166],2.3488,48.85341,{"lat":166,"lon":165},[169,172,175],{"name":170,"role":37,"phone":25,"phoneExt":25,"email":171},"Dominique THABUT, MDPHD","Dominique.thabut@aphp.fr",{"name":173,"role":37,"phone":25,"phoneExt":25,"email":174},"Florence BERGERON","florence.bergeron@aphp.fr",{"name":170,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":177,"status":111,"city":178,"state":25,"zip":179,"country":50,"countryCode":51,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Chu Poitiers","Poitiers","86000",{"type":53,"coordinates":181},[182,183],0.34348,46.58261,{"lat":183,"lon":182},[186,189],{"name":187,"role":37,"phone":25,"phoneExt":25,"email":188},"Valentin ROLLE, MD PHD","Valentin.ROLLE@chu-poitiers.fr",{"name":190,"role":37,"phone":25,"phoneExt":25,"email":191},"Laetitia ROULEAU","laetitia.rouleau@chu-poitiers.fr",{"facility":193,"status":47,"city":194,"state":25,"zip":195,"country":50,"countryCode":51,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Chu Pontchaillou","Rennes","35000",{"type":53,"coordinates":197},[198,199],-1.67431,48.11109,{"lat":199,"lon":198},[202,206,210,211],{"name":203,"role":37,"phone":204,"phoneExt":25,"email":205},"Edouard BARDOU-JACQUET, MDPHD","0299284298","edouard.bardou-jacquet@chu-rennes.fr",{"name":207,"role":37,"phone":208,"phoneExt":25,"email":209},"Solange SEGUIN","0299289889","Solange.SEGUIN@chu-rennes.fr",{"name":203,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":212,"role":70,"phone":25,"phoneExt":25,"email":25},"Caroline JEZEQUEL, MD",{"facility":214,"status":47,"city":215,"state":25,"zip":216,"country":50,"countryCode":51,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Toulouse University Hospital","Toulouse","31000",{"type":53,"coordinates":218},[219,220],1.44367,43.60426,{"lat":220,"lon":219},[223,227],{"name":224,"role":37,"phone":225,"phoneExt":25,"email":226},"Christophe BUREAU, MD PhD","+335 61 77 22 63","Bureau.c@chu-toulouse.fr",{"name":228,"role":33,"phone":25,"phoneExt":25,"email":25},"Christophe BUREAU, MDPHD",{"type":230,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100324660","medical-economic-evaluation-of-the-care-of-refractory-ascites-by-implantation-of-alfapump-device-in-cirrhotic-patients-100324660",false,"NCT03506893","Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients","ARIAPUMP","Inclusion Criteria:\n\n* Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.\n* Patient with an estimated life expectancy of at least 6 months on the day of inclusion.\n* Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS\n* Patient affiliated with or in receipt of social security\n* Informed and written consent signed by the patient.\n\nExclusion Criteria:\n\n* Local or systemic infection in the month preceding the procedure\n* Hepatocellular carcinoma with palliative care\n* MELD Score \\> 18\n* Child Pugh C Score \\> 10\n* Creatinine Clearance \\\u003C 50 ml\u002Fmn\n* Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion\n* Contraindication to general anesthesia\n* Contraindication to implant surgery of the device:\n\n  * Obstructive urological impairment\n  * Partitioning of ascites\n  * Coagulopathy\n* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure).\n* Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.","ALL","18 Years",{"count":241,"type":242},90,"ESTIMATED","INTERVENTIONAL",[245],"NA","The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately\n\nEvaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.",[248,249,250],"Ascites","Paracentesis","Cirrhosis",[252,253],"refractory ascite","pump system","2025-03-25",{"date":256,"type":257},"2025-03-30","ACTUAL",{"date":259,"type":257},"2018-07-17",{"date":261,"type":242},"2027-05-31",{"name":5,"class":6},10]