GAVE - Gastric Antral Vascular EctasiaGAVENCT06830317
Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
An observational study of GAVE - Gastric Antral Vascular Ectasia, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GAVE - Gastric Antral Vascular Ectasia
- What is being tested?
- Endoscopic Radiofrequency treatment and QoL EQ5D questionaire
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2025to 2 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the 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
- Being tested
- Endoscopic Radiofrequency treatment, QoL EQ5D questionaire
- Keywords
- GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION
- Medical subject headings
- Gastric Antral Vascular Ectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Radiofrequency treatmentProcedure or surgery
Also called RFA with a TTS catheter at 12 Joule/cm2
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 questionaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| cohort | Patients with existing diagnosis of GAVE (validated by an external expert) Receives: Procedure: Endoscopic Radiofrequency treatment; Other: QoL EQ5D questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter)
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
Measured: 1 year from enrolling plus six months of follow-up
Secondary outcomes (3)
patient's need for transfusions and/or infusions of i.v. iron supplementation
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.
Measured: 6 and 12 months after the end of RFA treatment
endoscopic evaluation of GAVE remission
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).
Measured: 1 year from enrolling plus six months of follow-up
cost-effectiveness analysis
cost-effectiveness analysis on the effects of Radiofrequency treatment in patients with GAVE.
Measured: 1 year from enrolling plus six months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start2 Apr 2025 (estimated)
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GAVE - Gastric Antral Vascular EctasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Antonio Pisani, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Antonio Pisani, MD, Principal investigator, National Institute of Gastroenterology Saverio De Bellis Research HospitalStefania Marangi, MD, Study chair, National Institute of Gastroenterology Saverio De Bellis Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830317
- Sponsor's protocol ID
- GAVE_STUDY
- Acronym
- GAVE
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available.
PubMed 13052170Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70.
PubMed 6332757Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112.
PubMed 14722858Suit PF, Petras RE, Bauer TW, Petrini JL Jr. Gastric antral vascular ectasia. A histologic and morphometric study of "the watermelon stomach". Am J Surg Pathol. 1987 Oct;11(10):750-7.
PubMed 3499091Shander A, Cappellini MD, Goodnough LT. Iron overload and toxicity: the hidden risk of multiple blood transfusions. Vox Sang. 2009 Oct;97(3):185-97. doi: 10.1111/j.1423-0410.2009.01207.x. Epub 2009 Aug 3.
PubMed 19663936Fuccio L, Mussetto A, Laterza L, Eusebi LH, Bazzoli F. Diagnosis and management of gastric antral vascular ectasia. World J Gastrointest Endosc. 2013 Jan 16;5(1):6-13. doi: 10.4253/wjge.v5.i1.6.
PubMed 23330048McCarty TR, Rustagi T. Comparative Effectiveness and Safety of Radiofrequency Ablation Versus Argon Plasma Coagulation for Treatment of Gastric Antral Vascular Ectasia: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2019 Sep;53(8):599-606. doi: 10.1097/MCG.0000000000001088.
PubMed 29952856Patel A, Patel S, Wickremesinghe PC, Vadada D. Radiofrequency ablation using Barrx(R) for the endoscopic treatment of gastric antral vascular ectasia: a series of three cases and a review of the literature on treatment options. Clin Exp Gastroenterol. 2017 Jul 10;10:113-120. doi: 10.2147/CEG.S80241. eCollection 2017.
PubMed 28744150Magee C, Lipman G, Alzoubaidi D, Everson M, Sweis R, Banks M, Graham D, Gordon C, Lovat L, Murray C, Haidry R. Radiofrequency ablation for patients with refractory symptomatic anaemia secondary to gastric antral vascular ectasia. United European Gastroenterol J. 2019 Mar;7(2):217-224. doi: 10.1177/2050640618814659. Epub 2018 Nov 15.
PubMed 31080606Hayashi S, Saeki S. Endoscopic microvascular architecture of the portale hypertensive gastric mucosa on narrow band imaging. Dig Endosc 2007; 19: 116-123.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06830317
- Acronym / sponsor ID
- GAVE / GAVE_STUDY
- Conditions
- GAVE - Gastric Antral Vascular Ectasia
- Keywords
- GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Apr 2025 (estimated)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Procedure: Endoscopic Radiofrequency treatment, Other: QoL EQ5D questionairePatients with existing diagnosis of GAVE (validated by an external expert) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Radiofrequency treatmentAlso: RFA with a TTS catheter at 12 Joule/cm2Treatment 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 | Procedure or surgery | cohort |
| QoL EQ5D questionaireQuality 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 | Other | cohort |
Primary outcome
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
3 secondary outcomes
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
endoscopic evaluation of GAVE remission
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 13052170RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available.
- Background: PubMed 6332757Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70.
- Background: PubMed 14722858Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112.
- Background: PubMed 3499091Suit PF, Petras RE, Bauer TW, Petrini JL Jr. Gastric antral vascular ectasia. A histologic and morphometric study of "the watermelon stomach". Am J Surg Pathol. 1987 Oct;11(10):750-7.
- Background: PubMed 19663936Shander A, Cappellini MD, Goodnough LT. Iron overload and toxicity: the hidden risk of multiple blood transfusions. Vox Sang. 2009 Oct;97(3):185-97. doi: 10.1111/j.1423-0410.2009.01207.x. Epub 2009 Aug 3.
- Background: PubMed 23330048Fuccio L, Mussetto A, Laterza L, Eusebi LH, Bazzoli F. Diagnosis and management of gastric antral vascular ectasia. World J Gastrointest Endosc. 2013 Jan 16;5(1):6-13. doi: 10.4253/wjge.v5.i1.6.
- Background: PubMed 29952856McCarty TR, Rustagi T. Comparative Effectiveness and Safety of Radiofrequency Ablation Versus Argon Plasma Coagulation for Treatment of Gastric Antral Vascular Ectasia: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2019 Sep;53(8):599-606. doi: 10.1097/MCG.0000000000001088.
- Background: PubMed 28744150Patel A, Patel S, Wickremesinghe PC, Vadada D. Radiofrequency ablation using Barrx(R) for the endoscopic treatment of gastric antral vascular ectasia: a series of three cases and a review of the literature on treatment options. Clin Exp Gastroenterol. 2017 Jul 10;10:113-120. doi: 10.2147/CEG.S80241. eCollection 2017.
- Background: PubMed 31080606Magee C, Lipman G, Alzoubaidi D, Everson M, Sweis R, Banks M, Graham D, Gordon C, Lovat L, Murray C, Haidry R. Radiofrequency ablation for patients with refractory symptomatic anaemia secondary to gastric antral vascular ectasia. United European Gastroenterol J. 2019 Mar;7(2):217-224. doi: 10.1177/2050640618814659. Epub 2018 Nov 15.
- BackgroundHayashi S, Saeki S. Endoscopic microvascular architecture of the portale hypertensive gastric mucosa on narrow band imaging. Dig Endosc 2007; 19: 116-123.
- Individual participant dataSharing planned: No
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Pisani, MD principal investigator
National Institute of Gastroenterology Saverio De Bellis Research Hospital
Stefania Marangi, MD study chair
National Institute of Gastroenterology Saverio De Bellis Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of GAVE - Gastric Antral Vascular Ectasia, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefania Marangi, MD (0804994233, dott.marangistefania@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830317, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.