NCT02617576

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

November 16, 2015

Last Update Submit

January 24, 2017

Conditions

Taste, Altered

Outcome Measures

Primary Outcomes (2)

  • the number of patients that prefer flavored contrast

    the number of patients that prefer flavored contrast will be evaluated by a questionaire

    one year

  • bowel diameter measurements on MR Enterography

    bowel diameter measurements will be made by two radiologists on MR Enterography

    one year

Study Arms (2)

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.

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients undergoing MR enterography examinations

You may qualify if:

  • pediatric patients having a MR enterography

You may not qualify if:

  • sedated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelly Dietz, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 1, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01