Oxygenation in Vascular Lesions of the Colon

Vascular Lesion Clinical Trial

Official title:

Oxygenation in Vascular Lesions of the Colon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230731
• Other study ID #: IRB23-1273
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Joel Pekow, MD
• Phone: (773) 834-8632
• Email: jpekow[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Lesion

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative analysis of colonic oxygen saturation levels	Colonic oxygen saturation levels will be compared between patients with vascular lesions of the colon and healthy controls.	baseline-12 months