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PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00876083
Acronym
IMAGE
Enrollment
44920
Registered
2009-04-06
Start date
2008-03-31
Completion date
2009-09-30
Last updated
2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Imaging

Keywords

Drug utilization review

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.

Interventions

DRUGUltravist (Iopromide, BAY86-4877)

Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frame
Occurrence of adverse eventsDuring and after Ultravist application on the day of examination

Secondary

MeasureTime frame
General contrast quality in the region of interest as assessed by physiciansOn the day of examination

Countries

Bosnia and Herzegovina, China, Germany, Hungary, Indonesia, Iran, Italy, Malaysia, Moldova, Pakistan, Philippines, Poland, Romania, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, Ukraine, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026