Video Capillaroscopy for Gastric Antral Vascular Ectasia

(GAVE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Dialysis, Diabetes, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a procedure called video capillaroscopy to determine if it can differentiate between patients with gastric antral vascular ectasia (GAVE) who have an autoimmune disease and those who do not. Participants will be divided into two groups: those with GAVE and a connective tissue disease, and those with GAVE without it. Eligible participants must have a GAVE diagnosis from a standard stomach exam called an EGD and must not have conditions like type 2 diabetes or psoriasis. As an unphased study, this trial offers a unique opportunity to contribute to medical knowledge and potentially enhance diagnostic methods for GAVE.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that video capillaroscopy is safe for patients with GAVE?

Research shows that video capillaroscopy, the treatment under study, is generally easy for patients to handle. This non-invasive procedure does not involve cutting into the body. It examines tiny blood vessels and is safe for patients. Studies have not reported any serious side effects from video capillaroscopy, suggesting its safety. Participants in previous studies did not experience major negative effects, indicating a positive safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about video capillaroscopy for Gastric Antral Vascular Ectasia (GAVE) because it offers a non-invasive way to assess the condition. Unlike standard treatments like endoscopic thermal ablation or medication, video capillaroscopy uses a small camera to examine blood vessels under the skin, potentially revealing new insights into vascular changes associated with GAVE. This approach could help identify underlying issues without requiring more invasive procedures. By providing a clearer picture of what's happening at a microvascular level, this technique might lead to more personalized and effective treatment plans for patients with GAVE.

What evidence suggests that video capillaroscopy is effective for distinguishing GAVE with autoimmune disease versus other conditions?

This trial will use video capillaroscopy to study patients with GAVE (gastric antral vascular ectasia) who either have connective tissue disease or do not. Research suggests that video capillaroscopy could help distinguish between these groups. This technique examines tiny blood vessels and might reveal patterns or issues related to the causes of GAVE. Although no direct evidence yet shows it can treat GAVE, capillaroscopy aids doctors in understanding blood vessel problems. This understanding might lead to identifying different groups of GAVE patients and customizing their treatments. Overall, the method seems promising for improving diagnosis rather than directly treating the condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Florentina Berianu, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with GAVE confirmed by EGD. It includes those with connective tissue disease and excludes individuals exposed to certain chemicals, under 18, with type 2 diabetes, specific hand conditions or trauma, vibratory tool use, pregnancy, bleeding disorders, psoriasis, COPD or on dialysis.

Inclusion Criteria

I have GAVE, with or without a connective tissue disease.

I am 18 or older and have been diagnosed with GAVE.

Exclusion Criteria

I have been diagnosed with anti-phospholipid syndrome.

Exposure to toluene or benzoyl

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo nail fold video capillaroscopy and EGD to assess microvascular abnormalities

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Video Capillaroscopy

Trial Overview The study tests if capillaroscopy can differentiate between GAVE patients with autoimmune diseases versus other causes based on their EGD results. It's a diagnostic research comparing two patient groups: one with an additional connective tissue diagnosis and the other without it.

How Is the Trial Designed?

Group I: GAVE without connective tissue disease Experimental Treatment 1 Intervention

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.

Group II: GAVE with CTD Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07127952

Correlations of the Microvascular Abnormalities on NVC ... The purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with GAVE ...

2. withpower.com withpower.com/trial/phase-gastric-antral-vascular-ectasia-4-2025-34fd9

Video Capillaroscopy for Gastric Antral Vascular Ectasia ... The purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with GAVE (gastric ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8366108/

Endoscopic treatment for gastric antral vascular ectasia Data on APC, RFA, or EBL alone were collected. The major outcomes of interests included endoscopic success rate, blood transfusion requirement, ...

4. patlynk.com patlynk.com/trial/NCT07127952

Microvascular Abnormalities in GAVE Patients Participants in this study will undergo a nail fold video capillaroscopy, a non-invasive procedure that examines the small blood vessels at the ...

5. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-022-02790-1

Gastric antral vascular ectasia in systemic sclerosis: a study of ... To describe the epidemiology, determinants and survival impact of gastric antral vascular ectasia (GAVE) in systemic sclerosis (SSc).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9386635/

Gastric Antral Vascular Ectasia (GAVE) a case report ... Gastric Antral Vascular Ectasia is a rare disorder that causes up to 4 % of severe acute gastrointestinal bleeding. It affects elderly females with iron ...

7. ctv.veeva.com ctv.veeva.com/study/correlations-of-the-microvascular-abnormalities-on-nvc-nail-fold-video-capillaroscopy-and-gave-ga

Correlations of the Microvascular Abnormalities on NVC (Nail ... The purpose of this research is to determine whether a procedure called capillaroscopy can help distinguish patients who are diagnosed with ...