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

February 11, 2025 updated by: Antonio Pisani, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants will have demonstrated inadequate response or intolerance to existing standard-of-care treatments, such as argon plasma coagulation (APC), proton pump inhibitors (PPIs), or somatostatin analogs. This ensures the study evaluates the novel therapy in a population where current interventions have limitations. Patients who have not yet received any treatment for GAVE will also be eligible to assess the efficacy of the new therapy as a first-line option

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort
Patients with existing diagnosis of GAVE (validated by an external expert)
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 Names:
  • RFA with a TTS catheter at 12 Joule/cm2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter)
Time Frame: 1 year from enrolling plus six months of follow-up
compare the number of transfusions per patient pre and post treatment with the evaluation of sustained increase in Hgb (at least Hgb 10.5 g/dl) per patient six months after at least two sequential RFA treatments
1 year from enrolling plus six months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's need for transfusions and/or infusions of i.v. iron supplementation
Time Frame: 6 and 12 months after the end of RFA treatment
evaluate the percentage of patients who achieve the goal of reducing the need for transfusion (respect of patient's clinical history) and/or infusions of i.v. iron supplementation.
6 and 12 months after the end of RFA treatment
endoscopic evaluation of GAVE remission
Time Frame: 1 year from enrolling plus six months of follow-up
evaluate endoscopic partial or total regression of areas of GAVE after Radiofrequency treatment (by asking expert endoscopist to estimate the overall percentage change in GAVE).
1 year from enrolling plus six months of follow-up
cost-effectiveness analysis
Time Frame: 1 year from enrolling plus six months of follow-up
cost-effectiveness analysis on the effects of Radiofrequency treatment in patients with GAVE.
1 year from enrolling plus six months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Collaborators

Medtronic

Investigators

  • Principal Investigator: Antonio Pisani, MD, National Institute of Gastroenterology Saverio De Bellis Research Hospital
  • Study Chair: Stefania Marangi, MD, National Institute of Gastroenterology Saverio De Bellis Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2025

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

September 2, 2027

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAVE_STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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