Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Trans… (NCT06830317) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
80 participantsStarted 2025-04-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* Able to comply with study requirements and understand and sign the informed consent form
Exclusion Criteria:
* 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
* Blood coagulation deficit: International normalized ratio (INR)\>2, Platelets (PLT) \<50,000
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter)
Timeframe: 1 year from enrolling plus six months of follow-up
Trial details
NCT IDNCT06830317
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis