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WithdrawnNCT02617576Updated Jan 25, 2017

Flavoring Oral Contrast for MR Enterography

An observational study in Taste, Altered, sponsored by University of Minnesota. Withdrawn. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
8 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Taste, Altered

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03

In context

Dysgeusia

52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.

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Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pediatric patients undergoing MR enterography examinations

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pediatric patients having a MR enterography

Exclusion criteria

Exclusion Criteria:

  • sedated patients
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. the number of patients that prefer flavored contrast

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

    Time frame: one year

  2. bowel diameter measurements on MR Enterography

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

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2015
First posted
Dec 1, 2015
Start
Jan 2016
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Jan 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02617576
Responsible party
Sponsor
First posted
Dec 1, 2015
Start date
Jan 2016
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 25, 2017

Study contacts

Kelly Dietz, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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