Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

80 Participants
are divided into 1 treatment group

Locations

This trial has no locations