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Ultrasound Evaluation of Crohn's Disease

NCT03235180 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-11-10

Study results available
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Summary

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

Conditions

  • Crohn Disease

Interventions

DRUG

Sulfur Hexafluoride

Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.

DEVICE

Ultrasound Elastography

Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

DEVICE

Ultrasound Vascularity

Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

DEVICE

Magnetic Resonance Enterography (MRE)

Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

Sponsors & Collaborators

Principal Investigators

  • Shigao Chen, PhD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2021-10-12
Completion
2021-10-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03235180 on ClinicalTrials.gov