Flavoring Oral Contrast for MR Enterography

January 24, 2017 updated by: University of Minnesota
To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography.

Study Overview

Status

Withdrawn

Conditions

Detailed 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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients undergoing MR enterography examinations

Description

Inclusion Criteria:

  • pediatric patients having a MR enterography

Exclusion Criteria:

  • sedated patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Flavored contrast
This group of patients will have the choice to flavor their contrast.
Unflavored contrast
This group of patients will drink the contrast without flavoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of patients that prefer flavored contrast
Time Frame: one year
the number of patients that prefer flavored contrast will be evaluated by a questionaire
one year
bowel diameter measurements on MR Enterography
Time Frame: one year
bowel diameter measurements will be made by two radiologists on MR Enterography
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Kelly Dietz, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1507M76622

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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