PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination
IMAGE
Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination
23 other identifiers
observational
44,920
21 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFebruary 28, 2011
February 1, 2011
1.5 years
April 3, 2009
February 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of adverse events
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
On the day of examination
Study Arms (1)
Group 1
Interventions
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Eligibility Criteria
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.
You may qualify if:
- Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (21)
Unknown Facility
Many Locations, Bosnia and Herzegovina
Unknown Facility
Many Locations, China
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Hungary
Unknown Facility
Many Locations, Indonesia
Unknown Facility
Many Locations, Iran
Unknown Facility
Many Locations, Italy
Unknown Facility
Many Locations, Malaysia
Unknown Facility
Many Locations, Moldova
Unknown Facility
Many Locations, Pakistan
Unknown Facility
Many Locations, Philippines
Unknown Facility
Many Locations, Poland
Unknown Facility
Many Locations, Romania
Unknown Facility
Many Locations, Russia
Unknown Facility
Many Locations, Saudi Arabia
Unknown Facility
Many Locations, Singapore
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Taiwan
Unknown Facility
Many Locations, Thailand
Unknown Facility
Many Locations, Ukraine
Unknown Facility
Many Locations, Vietnam
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
March 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
February 28, 2011
Record last verified: 2011-02