[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579901":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":35,"locations":10,"responsibleParty":44,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":10},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"cohort",null,"Patients with existing diagnosis of GAVE (validated by an external expert)",[13,14],"Procedure: Endoscopic Radiofrequency treatment","Other: QoL EQ5D questionaire",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Endoscopic Radiofrequency treatment","Treatment with RFA will carried out with focal RFA with a TTS catheter at 12 Joule\u002Fcm2 to all visible areas of GAVE under conscious sedation or propofol sedation by experienced team of endoscopists and anesthetists",[9],[22],"RFA with a TTS catheter at 12 Joule\u002Fcm2",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"QoL EQ5D questionaire","Quality of Life EQ5D (by EuroQol Group) before every RFA treatment and at Follow up visits (3, 6 and 12 months after the first procedure). QoL questionnaire EQ5D The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his\u002Fher health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state",[9],[28,32],{"name":29,"affiliation":30,"role":31},"Antonio Pisani, MD","National Institute of Gastroenterology Saverio De Bellis Research Hospital","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":34},"Stefania Marangi, MD","STUDY_CHAIR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","0804994233","dott.marangistefania@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Maurizio Polignano","0804994365","maurizio.polignano@irccsdebellis.it",{"type":31,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Antonio Pisani","MD",[48],{"name":49,"class":50},"Medtronic","INDUSTRY","100579901","study-on-the-efficacy-of-endoscopic-radiofrequency-treatment-in-reducing-the-need-for-blood-transfusions-in-gave-100579901",false,"NCT06830317","Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE","A Multicenter, Observational, Prospective Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions Compared with Conventional Therapies in Patients with Gastric Antral Vascular Ectasia (GAVE)","GAVE","Inclusion Criteria:\n\n* At least 18 years of age\n* Existing diagnosis of GAVE (validated by an external expert)\n* Melena and\u002For hematemesis secondary to GAVE and\u002For iron deficiency anemia persisting despite systemic iron therapy or oral supplementation and\u002For (concentrated red globules) GRC transfusions for at least 6 months\n* Negative colonoscopy (performed within 12 months prior to enrollment, exclusion of any site of bleeding)\n* Able to comply with study requirements and understand and sign the informed consent form\n\nExclusion Criteria:\n\n* Alternative causes for iron deficiency anemia (gastro-duodenal erosions and\u002For ulcerations, celiac disease, Inflammatory Bowel Disease (IBD), etc)\n* Pregnancy\n* Active malignancy (malignancy diagnosed in past five years or ongoing treatment)\n* Anatomical malformations precluding treatment with RFA\n* Blood coagulation deficit: International normalized ratio (INR)\\>2, Platelets (PLT) \\\u003C50,000","ALL","18 Years",{"count":62,"type":63},80,"ESTIMATED","OBSERVATIONAL","The aim of the study therefore is to permanently resolve the existence of the bleeding sites caused by Gave and reduce both bleeding episodes and the need for transfusion in such patients applying \"Barrx\" (trademark) radiofrequency endoscopic ablation technology in selected cohort of patients that will be defined the patient inclusion section.",[67],"GAVE - Gastric Antral Vascular Ectasia",[69],"GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION","NOT_YET_RECRUITING","2025-02-11",{"date":73,"type":74},"2025-02-17","ACTUAL",{"date":76,"type":63},"2025-04-02",{"date":78,"type":63},"2027-09-02",{"name":5,"class":6}]