Enrolling by invitation
GAVE

Microvascular Abnormalities in GAVE Patients

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What is being tested

Video Capillaroscopy

Device
Who is being recruted

Gastric Antral Vascular Ectasia

From 18 to 95 Years
+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: May 2025

See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 3, 2025Actual date on which the first participant was enrolled.

This study focuses on understanding a condition called Gastric Antral Vascular Ectasia (GAVE), often referred to as "watermelon stomach," which can cause gastrointestinal bleeding. The researchers aim to find out how common certain abnormalities are in the tiny blood vessels near the nails, using a method called nail fold video capillaroscopy (NVC), in patients who have GAVE. This study is important because it may reveal patterns that can help doctors better understand and treat GAVE, potentially improving patient care. Participants in this study will undergo a nail fold video capillaroscopy, a non-invasive procedure that examines the small blood vessels at the base of the fingernails. They will also have an endoscopic examination of the stomach lining, called an EGD, to observe the GAVE. The study will compare findings from the NVC with how the patients present clinically, which means looking at their symptoms and other medical indicators. By doing this, the study aims to draw connections between these examinations and the patients' experiences.

Official TitleCorrelations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD 
Principal SponsorMayo Clinic
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
75 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 95 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Gastric Antral Vascular Ectasia
Criteria
2 inclusion criteria required to participate
Patients 18 years and older with gave diagnosis as pair EGD performed in Gastroenterology as standard of care
atients with GAVE with connective tissue disease will be compared to patients with GAVE without a connective tissue disease
1 exclusion criteria prevent from participating
Age less than 18 years of age, pregnant individuals, dialysis dependent, type 2 diabetes, recent hand trauma or manicure (<2 weeks), routine use of vibratory tools, history of acrocyanosis or erythromelalgia, previous diagnosis of a bleeding disorder, diagnosis of psoriasis, diagnosis of anti-phospholipid syndrome, exposure to toluene or benzoyl, diagnosis of psoriasis, diagnosis of COPD

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Will include patients between 18 and 95 years old seen at Mayo Clinic in Florida who were diagnosed with GAVE (Gastric antral vascular ectasia) based on the EGD findings. Will include patients with gave and connective tissue disease. Patient can be identified using slicer dicer or advanced text explorer and will be invited to have a nail fold video capillaroscopy.
Group II
Will include patients between 18 and 95 seen at Mayo Clinic in Florida who were diagnosed with GAVE based on the EGD findings. Will include patients with GAVE without connective tissue disease Patient can be identified using slicer dicer or advanced text explorer and will be invited to have a nail fold video capillaroscopy.
Study Objectives
Primary Objectives

Defined the prevalence and phenotype of nail fold video capillaroscopy abnormalities in patients with G.A.V.E.
Secondary Objectives

To compare the findings of and VC and clinical manifestation and organ involvement patients with gave and connective tissue disease to those with gave without connective tissue disease.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Mayo Clinic (Florida)Jacksonville, United StatesSee the location
Enrolling by invitationOne Study Center