Gastric Antral Vascular EctasiaGAVENCT07127952
Correlations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD
A study testing Video Capillaroscopy in people with Gastric Antral Vascular Ectasia, run by Mayo Clinic at 3 sites in United States.
Trial summary
The purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with GAVE (gastric antral vascular ectasia) with an autoimmune disease versus idiopathic/other conditions based on EGD findings. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastric Antral Vascular Ectasia
- What is being tested?
- Video Capillaroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2025to 31 Dec 2026
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older with gave diagnosis as pair EGD performed in Gastroenterology as standard of care.
- Patients with GAVE with connective tissue disease will be compared to patients with GAVE without a connective tissue disease.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
Mayo Clinic Health Systems
Eau Claire, Wisconsin, 54703-5211
Mayo Clinic (Florida)
Jacksonville, Florida, 32224
About this study
The purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with GAVE (gastric antral vascular ectasia) with an autoimmune disease versus idiopathic/other conditions based on EGD findings.
Read the detailed description
The primary aim of this study is to define the prevalence and findings (as per quantification) of nail fold video capillaroscopy abnormalities in patients with GAVE. The secondary aim is to compare the findings of NVC and clinical presentation in patients with GAVE.
- Conditions
- Gastric Antral Vascular Ectasia
- Being tested
- Video Capillaroscopy
- Keywords
- GAVE, G.A.V.E, Gastric Antral Vascular, Gastric Antral Vascular Ectasia
- 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.
Video CapillaroscopyDevice
Also called Nailfold Video Capillaroscopy
A non-invasive imaging technique used to assess capillary structure and morphology in the nailfold area, commonly used in evaluating microvascular changes associated with connective tissue diseases.
| Study group | Role | What they receive |
|---|---|---|
| GAVE with CTD | Other | 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. Receives: Device: Video Capillaroscopy |
| GAVE without connective tissue disease | Other | 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. Receives: Device: Video Capillaroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and Phenotypic with G.A.V.E
Defined the prevalence and phenotype of nail fold video capillaroscopy abnormalities in patients with G.A.V.E.
Measured: From enrollment to end of study once the accrual has been met within baseline of Day 1
Secondary outcomes (1)
Comparing Findings
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.
Measured: From enrollment to end of study once the accrual has been met within baseline of day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start3 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Antral Vascular EctasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florentina Berianu, Mayo Clinic
- Investigators
- Florentina Berianu, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127952
- Sponsor's protocol ID
- 25-001900
- Acronym
- GAVE
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At this time, it has not been determined whether individual participant data (IPD) will be shared. The decision will depend on factors such as regulatory requirements, ethical considerations, and sponsor policies. If IPD sharing is implemented, appropriate safeguards will be in place to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD
- ClinicalTrials.gov ID
- NCT07127952
- Acronym / sponsor ID
- GAVE / 25-001900
- Conditions
- Gastric Antral Vascular Ectasia
- Keywords
- GAVE, G.A.V.E, Gastric Antral Vascular, Gastric Antral Vascular Ectasia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Aug 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 purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with GAVE (gastric antral vascular ectasia) with an autoimmune disease versus idiopathic/other conditions based on EGD findings.
Detailed description
The primary aim of this study is to define the prevalence and findings (as per quantification) of nail fold video capillaroscopy abnormalities in patients with GAVE. The secondary aim is to compare the findings of NVC and clinical presentation in patients with GAVE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAVE with CTD | Other | Device: Video CapillaroscopyWill 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. |
| GAVE without connective tissue disease | Other | Device: Video CapillaroscopyWill 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older with gave diagnosis as pair EGD performed in Gastroenterology as standard of care.
- Patients with GAVE with connective tissue disease will be compared to patients with GAVE without a connective tissue disease.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Video CapillaroscopyAlso: Nailfold Video CapillaroscopyA non-invasive imaging technique used to assess capillary structure and morphology in the nailfold area, commonly used in evaluating microvascular changes associated with connective tissue diseases. | Device | GAVE with CTD, GAVE without connective tissue disease |
Primary outcome
Prevalence and Phenotypic with G.A.V.E
Time frame: From enrollment to end of study once the accrual has been met within baseline of Day 1
Defined the prevalence and phenotype of nail fold video capillaroscopy abnormalities in patients with G.A.V.E.
1 secondary outcome
Comparing Findings
Time frame: From enrollment to end of study once the accrual has been met within baseline of day 1
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 29 Jan 2026.
- Individual participant dataSharing planned: Undecided. At this time, it has not been determined whether individual participant data (IPD) will be shared. The decision will depend on factors such as regulatory requirements, ethical considerations, and sponsor policies. If IPD sharing is implemented, appropriate safeguards will be in place to protect participant confidentiality.
Related trials for Gastric Antral Vascular Ectasia
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Recruiting
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Gastric Antral Vascular Ectasia
Not yet recruitingObservational study
Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
GAVE - Gastric Antral Vascular Ectasia
Not yet recruiting
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
Liver Cirrhosis, Gastric Antral Vascular Ectasia
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.
Florentina Berianu, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Capillaroscopy in people with Gastric Antral Vascular Ectasia, run by Mayo Clinic at 3 sites in United States.
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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Phenotypic with G.A.V.E (time frame: From enrollment to end of study once the accrual has been met within baseline of Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.