[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579901":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":37,"overallOfficials":49,"centralContacts":57,"locations":24,"responsibleParty":66,"collaborators":69,"id":73,"slug":24,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":24,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":24,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":24},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams\u002Fdeciliter)","compare the number of transfusions per patient pre and post treatment with the evaluation of sustained increase in Hgb (at least Hgb 10.5 g\u002Fdl) per patient six months after at least two sequential RFA treatments","1 year from enrolling plus six months of follow-up",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"patient's need for transfusions and\u002For infusions of i.v. iron supplementation","evaluate the percentage of patients who achieve the goal of reducing the need for transfusion (respect of patient's clinical history) and\u002For infusions of i.v. iron supplementation.","6 and 12 months after the end of RFA treatment",{"measure":19,"description":20,"timeFrame":12},"endoscopic evaluation of GAVE remission","evaluate endoscopic partial or total regression of areas of GAVE after Radiofrequency treatment (by asking expert endoscopist to estimate the overall percentage change in GAVE).",{"measure":22,"description":23,"timeFrame":12},"cost-effectiveness analysis","cost-effectiveness analysis on the effects of Radiofrequency treatment in patients with GAVE.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","In the period from March 2025 to June 2027 n. 80 patients from 21 different medical Centers across Italy will be screened and their endoscopic findings will be shared centrally for the approval and confirmation of the GAVE diagnosis.\n\nFormal written informed consent will take from patients to join the study. The study will be approved by our Ethics Committee of the promoting center (conforming to the 1975 Declaration of Helsinki).\n\nInclusion and exclusion criteria will be applied until the expected sample size is reached.\n\nFollowing the GAVE diagnosis confirmation, all consecutive patients will be enrolled in the study and directed to the initial assessment before the treatment procedures. It is estimated that each center will aim to enroll n. 3-5 of pts in the participating centers over the next 24 months.\n\nTreatment with Radiofrequency will carried out with focal Radiofrequency (RFA) with a through the scope (TTS) catheter at 12 J\u002Fcm2 to all visible areas of GAVE under conscious sedation or propofol sedation by experienced team of endoscopists and anesthetists. Prior to treatment, 2% N-acetylcysteine as a mucolytic will be applied.\n\nAll patients received pantoprazole (40 mg twice daily) and sucralfate (1 g three times per day) post-endoscopy for 4 weeks.\n\nFollowing RFA procedures, all patients will return for a repeat endoscopy after 6 weeks for follow up post-treatment. In those for whom there will macroscopic GAVE present at this endoscopy, this will treated with Radiofrequency as at the initial therapy.\n\nAfter 8 weeks following this, patients will return for a follow-up endoscopy during which images will captured of the gastric mucosa and will enter the follow-up phase during which Hb and ongoing transfusion\u002Firon supplement will record at six and 12 months following the first procedure.","Participants will have demonstrated inadequate response or intolerance to existing standard-of-care treatments, such as argon plasma coagulation (APC), proton pump inhibitors (PPIs), or somatostatin analogs. This ensures the study evaluates the novel therapy in a population where current interventions have limitations. Patients who have not yet received any treatment for GAVE will also be eligible to assess the efficacy of the new therapy as a first-line option",[31],{"label":32,"type":24,"description":33,"interventionNames":34},"cohort","Patients with existing diagnosis of GAVE (validated by an external expert)",[35,36],"Procedure: Endoscopic Radiofrequency treatment","Other: QoL EQ5D questionaire",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"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",[32],[44],"RFA with a TTS catheter at 12 Joule\u002Fcm2",{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":24},"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",[32],[50,54],{"name":51,"affiliation":52,"role":53},"Antonio Pisani, MD","National Institute of Gastroenterology Saverio De Bellis Research Hospital","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":52,"role":56},"Stefania Marangi, MD","STUDY_CHAIR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":24,"email":61},"CONTACT","0804994233","dott.marangistefania@gmail.com",{"name":63,"role":59,"phone":64,"phoneExt":24,"email":65},"Maurizio Polignano","0804994365","maurizio.polignano@irccsdebellis.it",{"type":53,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Antonio Pisani","MD",[70],{"name":71,"class":72},"Medtronic","INDUSTRY","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":83,"type":84},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.",[88],"GAVE - Gastric Antral Vascular Ectasia",[90],"GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION","NOT_YET_RECRUITING","2025-02-11",{"date":94,"type":95},"2025-02-17","ACTUAL",{"date":97,"type":84},"2025-04-02",{"date":99,"type":84},"2027-09-02",{"name":5,"class":6}]