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Recruiting NCT06230731

Oxygenation in Vascular Lesions of the Colon

No phase Interventional Vascular Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxygen saturation.
Who it may be relevant to
Registry conditions: Vascular Lesion. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.

Detailed description

The etiology of acquired vascular abnormalities of the large bowel (i.e. angiodysplasia, AVM, hemangiomas of the cecum. etc.) are unknown. These lesions typical appear as ectatic, dilated, and tortuous blood vessels within the submucosa and mucosa of the GI tract. In some patients they are the cause of acute large volume bleeding or a slower chronic bleed that manifests as chronic iron deficiency anemia. These lesions are more common in older individuals and those with underlying cardiac, pulmonary, and renal disease. As such, it is hypothesized that these lesions may result from chronic hypoxia. This study aims to evaluate oxygenation of the colon in people with acquired vascular abnormalities in the proximal colon compared to healthy controls.

Interventions

  • Other Oxygen saturation
    Measure oxygen levels in 5 proximal colon mucosa locations.

Primary outcome measures

  • Quantitative analysis of colonic oxygen saturation levels [Time frame: baseline-12 months]

Eligibility criteria

Inclusion criteria

  • Undergo standard of care colonoscopy
  • People with a history of vascular lesions of the colon
  • People with healthy colon
  • 18 - 89 years of age

Exclusion criteria

  • Age < 18 years
  • Age > 90 years
  • People with ulcerations in at ascending colon opposite the ileocecal valve
  • Previous colon surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • University of Chicago — Chicago

Identifiers

NCT: NCT06230731 · IRB23-1273

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗