About this trial
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.
Eligibility criteria
Qualifiers
At least 18 years of age
Existing diagnosis of GAVE (validated by an external expert)
Melena and/or hematemesis secondary to GAVE and/or iron deficiency anemia persisting despite systemic iron therapy or oral supplementation and/or (concentrated red globules) GRC transfusions for at least 6 months
Negative colonoscopy (performed within 12 months prior to enrollment, exclusion of any site of bleeding)
Disqualifiers
Alternative causes for iron deficiency anemia (gastro-duodenal erosions and/or ulcerations, celiac disease, Inflammatory Bowel Disease (IBD), etc)
Pregnancy
Active malignancy (malignancy diagnosed in past five years or ongoing treatment)
Anatomical malformations precluding treatment with RFA
Trial design
Treatments tested in this trial
- Endoscopic Radiofrequency treatment
- QoL EQ5D questionaire
Treatment groups
Locations
Sponsors and collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
Medtronic
Collaborator