Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis

NCT03863886 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-29

No results posted yet for this study

Summary

Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel disease, they differ substantially in disease behavior, prognosis, and treatment paradigm. However, making an accurate diagnosis of Crohn's disease versus ulcerative colitis and assessing disease activity beyond the level of mucosal inflammation remain challenging with contemporary modalities. The objective of the study is to determine the novel role of endoscopic ultrasound in A) differentiating Crohn's colitis versus ulcerative colitis and B) monitoring disease activity in these patients.

Conditions

Interventions

PROCEDURE

Endoscopic ultrasound catheter (UM-2R/3R, Olympus)

A miniprobe ultrasound catheter (UM-2R/3R, Olympus) will be passed into the colonoscope's accessory channel at the time of colonoscopy to measure the thickness of the different colon wall layers (mucosa, submucosa, muscular propria, and total wall thickness) in the cecum and rectum.

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Vu Q Nguyen, M.D. · Assistant Professor of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2022-01-31
Completion
2022-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863886 on ClinicalTrials.gov