Oxygenation in Vascular Lesions of the Colon

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

Study Overview

• Status: Recruiting
• Conditions: Vascular Lesion
• Intervention / Treatment: Other: Oxygen saturation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristi Kearney, RN; Phone Number: 773-834-7414; Email: kkearney@bsd.uchicago.edu
• Study Contact Backup: Name: Joel Pekow, MD; Phone Number: (773) 834-8632; Email: jpekow@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Kristi Kearney, RN; Phone Number: 773-834-7414; Email: kkearney@bsd.uchicago.edu
      • Contact: Joel Pekow, MD; Phone Number: 773-834-8632; Email: jpekow@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vascular abnormality group; People with acquired vascular abnormalities in the proximal colon	Other: Oxygen saturation; Measure oxygen levels in 5 proximal colon mucosa locations.
Active Comparator: Control group; People with healthy colon	Other: Oxygen saturation; Measure oxygen levels in 5 proximal colon mucosa locations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Joel Pekow, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB23-1273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No