Diagnostic ImagingIMAGENCT00876083
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination
An observational study of Diagnostic Imaging, run by Bayer at 21 sites in 21 countries.
Trial summary
The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Ultravist (Iopromide, BAY86-4877)
- How many people
- 44,920 participants
- Where
- 21 sitesin 21 countries
- Study dates
- Mar 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of female and male patients who require an X-ray examination with contrast enhancement. Physicians should consult the full prescribing information for Ultravist before enrolling patients and familiarize themselves with the safety information in the product package label.
Who may be able to join
- Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Who cannot join
- No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
About this study
Official title: Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination
The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.
- Conditions
- Diagnostic Imaging
- Being tested
- Ultravist (Iopromide, BAY86-4877)
- Keywords
- Drug utilization review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultravist (Iopromide, BAY86-4877)Drug
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Ultravist (Iopromide, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: During and after Ultravist application on the day of examination
Secondary outcomes (1)
General contrast quality in the region of interest as assessed by physicians
Measured: On the day of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876083
- Sponsor's protocol ID
- 14692
- Other IDs
- UV0701, 13422, 13421, 14480, 13276, 14336, 14181, 13602
- Acronym
- IMAGE
- Status last verified
- Feb 2011
- First submitted
- 3 Apr 2009
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination
- ClinicalTrials.gov ID
- NCT00876083
- Acronym / sponsor ID
- IMAGE / 14692
- Conditions
- Diagnostic Imaging
- Keywords
- Drug utilization review
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44,920 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Apr 2009 (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.
The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Ultravist (Iopromide, BAY86-4877) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of female and male patients who require an X-ray examination with contrast enhancement. Physicians should consult the full prescribing information for Ultravist before enrolling patients and familiarize themselves with the safety information in the product package label.
Key inclusion criteria (1 listed)
- Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Key exclusion criteria (1 listed)
- No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultravist (Iopromide, BAY86-4877)Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist. | Drug | Group 1 |
Primary outcome
Occurrence of adverse events
Time frame: During and after Ultravist application on the day of examination
1 secondary outcome
General contrast quality in the region of interest as assessed by physicians
Time frame: On the day of examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
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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.
Bayer Study Director study director
Bayer
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging, run by Bayer at 21 sites in 21 countries.
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: finished, as of the sponsor's last update on 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Bosnia and Herzegovina, China, Germany, Hungary, Indonesia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of adverse events (time frame: During and after Ultravist application on the day of examination). 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 28 Feb 2011.