Correlations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD

NCT07127952 | Enrolling By Invitation FDA Device

• 1 other identifier: 25-001900
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastric Antral Vascular Ectasia

Keywords

GAVE; G.A.V.E; Gastric Antral Vascular; Gastric Antral Vascular Ectasia

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to end of study once the accrual has been met within baseline of Day 1

Secondary Outcomes (1)

• Comparing Findings

  From enrollment to end of study once the accrual has been met within baseline of day 1

Study Arms (2)

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.

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.

Device: Video Capillaroscopy

Interventions

Video Capillaroscopy DEVICE

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.

Also known as: Nailfold Video Capillaroscopy

GAVE with CTD; GAVE without connective tissue disease

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic (Florida)

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health Systems

Eau Claire, Wisconsin, 54703-5211, United States

Location

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Florentina Berianu, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 17, 2025
• Study Start: May 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (3)