NCT06230731

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Feb 2024Feb 2029

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

January 19, 2024

Last Update Submit

June 5, 2025

Conditions

Vascular Lesion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vascular abnormality group

EXPERIMENTAL

People with acquired vascular abnormalities in the proximal colon

Other: Oxygen saturation

Control group

ACTIVE COMPARATOR

People with healthy colon

Other: Oxygen saturation

Interventions

Oxygen saturationOTHER

Measure oxygen levels in 5 proximal colon mucosa locations.

Control groupVascular abnormality group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Interventions

Oxygen Saturation

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

  • Joel Pekow, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Pekow, MD

CONTACT

(773) 834-8632jpekow@bsd.uchicago.edu

Kristi Kearney, RN

CONTACT

773-834-7414Kkearney@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)