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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Formal 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). Inclusion and exclusion criteria will be applied until the expected sample size is reached. Following 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. Treatment with Radiofrequency will carried out with focal Radiofrequency (RFA) with a through the scope (TTS) catheter at 12 J/cm2 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. All patients received pantoprazole (40 mg twice daily) and sucralfate (1 g three times per day) post-endoscopy for 4 weeks. Following 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. After 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/iron supplement will record at six and 12 months following the first procedure.

Conditions

• GAVE - Gastric Antral Vascular Ectasia

Interventions

Type	Name	Description
PROCEDURE	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
OTHER	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

Timeline

• Start date: 2025-04-02
• Primary completion: 2027-07-02
• Completion: 2027-09-02
• First posted: 2025-02-17
• Last updated: 2025-02-17