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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02617576
Other study ID # 1507M76622
Secondary ID
Status Withdrawn
Phase N/A
First received November 16, 2015
Last updated January 24, 2017
Start date January 2016
Est. completion date December 2016

Study information

Verified date January 2017
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography.


Description:

Volumen is an oral contrast agent used in MR imaging of the bowel. It has an unpleasant taste which makes it difficult for pediatric patients, especially sick pediatric patients, to drink. There are other contrast materials used in the department that are flavored to improved patient participation. The investigators hope to determine a way to flavor Volumen to improve patient participation. In doing so, the investigators hope to also improve patient satisfaction as well as imaging quality.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- pediatric patients having a MR enterography

Exclusion Criteria:

- sedated patients

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Outcome

Type Measure Description Time frame Safety issue
Primary the number of patients that prefer flavored contrast the number of patients that prefer flavored contrast will be evaluated by a questionaire one year
Primary bowel diameter measurements on MR Enterography bowel diameter measurements will be made by two radiologists on MR Enterography one year
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