Taste, AlteredNCT02617576
Flavoring Oral Contrast for MR Enterography
An observational study of Taste, Altered, run by University of Minnesota.
Trial summary
To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Taste, Altered
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients undergoing MR enterography examinations
Who may be able to join
- pediatric patients having a MR enterography
Who cannot join
- sedated patients
About this study
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.
- Conditions
- Taste, Altered
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
the number of patients that prefer flavored contrast
the number of patients that prefer flavored contrast will be evaluated by a questionaire
Measured: one year
bowel diameter measurements on MR Enterography
bowel diameter measurements will be made by two radiologists on MR Enterography
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste, AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Dietz, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617576
- Sponsor's protocol ID
- 1507M76622
- Status last verified
- Jan 2017
- First submitted
- 16 Nov 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavoring Oral Contrast for MR Enterography
- ClinicalTrials.gov ID
- NCT02617576
- Acronym / sponsor ID
- 1507M76622
- Conditions
- Taste, Altered
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing MR enterography examinations
Key inclusion criteria (1 listed)
- pediatric patients having a MR enterography
Key exclusion criteria (1 listed)
- sedated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
bowel diameter measurements on MR Enterography
Time frame: one year
bowel diameter measurements will be made by two radiologists on MR Enterography
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Dietz, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Taste, Altered, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients that prefer flavored contrast (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.