[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488502":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":11,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LAMS gastro-gastrostomy","EXPERIMENTAL",null,[13],"Device: The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System","EUS-guided gastro-gastrostomy using the Hot Axios device: Using a therapeutic endoscopic ultrasound endoscope with a working channel of 3.7mm and under fluoroscopic control, the excluded stomach will be identified and punctured with a 19G needle. Contrast injection will confirm the good position of the needle in the excluded stomach. If needed, the excluded stomach will be filled with blue-stained aqua (5% indigocarmine) until a sufficient distension is obtained for placement of the lumen-apposing metal stent. A lumen-apposing metal stent with a diameter of 20mm will be used according to the manufacterers' instructions to create a gastrogastrostomy. Position will be checked with fluoroscopy.",[9],[21],"LAMS",[23],{"name":24,"affiliation":5,"role":25},"Pieter Hindryckx, Prof.","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":11,"email":30},"CONTACT","093320726","pieter.hindryckx@uzgent.be",[32,49],{"facility":33,"status":34,"city":35,"state":11,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"AZ Sint-Jan Brugge","RECRUITING","Bruges","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],3.22424,51.20892,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":11,"email":48},"Christophe Snauwaert, Dr.","0486804952","Christophe.Snauwaert@azsintjan.be",{"facility":5,"status":34,"city":50,"state":11,"zip":51,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Ghent","9000",{"type":39,"coordinates":53},[54,55],3.71667,51.05,{"lat":55,"lon":54},[58,61],{"name":59,"role":28,"phone":60,"phoneExt":11,"email":30},"Pieter Hindryckx, MD, PhD","+32 9 332 07 26",{"name":59,"role":25,"phone":11,"phoneExt":11,"email":11},{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100488502","endoscopic-ultrasound-guided-large-diameter-lumen-apposing-metal-stent-gastro-gastrostomy-for-bypass-reversal-in-patients-with-roux-en-y-gastric-bypass-100488502",false,"NCT05640947","Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass","Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass: a Proof of Concent Study","LABOR","Inclusion Criteria:\n\n* Group 1) patients needing any kind of parenteral nutritional support (eg. hypo- albuminemia, hypovitaminoses, mineral deficiencies,...) that can not be corrected by dietary intervention\u002Foral supplementation\n* Group 2) patients with persistent invalidating symptomatic dumping syndrome despite optimal dietary intervention (typical complaints are headache, sweating, trembling, weakness and feeling hungry).\n* Group 3) patients with a refractory marginal ulcers with stenosis of the gastrojejunostomy leading to feading difficulties.\n* Group 4) patients with F3 or F4 liver fibrosis and a tendency to decompensation after bypass surgery, as demonstrated by an increase in serum bilirubin\u002FINR and\u002For lowering of serum albumin.\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy\n2. Presence of significant portal hypertension as demonstrated by 2.1) the presence of esophageal and\u002For gastric varices AND\u002FOR 2.2) a hepatic venous pressure gradient (if measured) equal to or more than 10mm Hg AND\u002FOR 2.3) the combination of\n\n   1. a platelet count \\\u003C150000\u002Fµl AND\n   2. liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).\n3. Pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis).\n4. Karnofsky index less than 60\n5. Vulnerable patients","ALL","18 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"NA","The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.",[82,83,84,85,86],"Hypoglycemia","Gastric Outlet Obstruction","Steatohepatitis","Parenteral Support","Gastric Bypass","2025-10-03",{"date":89,"type":90},"2025-10-08","ACTUAL",{"date":92,"type":90},"2023-01-30",{"date":94,"type":76},"2028-02",{"name":5,"class":6},2]