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Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2025-04-02
Completion Date
2027-09-02
Last Updated
2025-02-17
Healthy Volunteers
No
Conditions
Interventions
Endoscopic Radiofrequency treatment
Treatment with RFA will carried out with focal RFA with a TTS catheter at 12 Joule/cm2 to all visible areas of GAVE under conscious sedation or propofol sedation by experienced team of endoscopists and anesthetists
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/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her 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