PMS 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.

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Key information

Conditions

Diagnostic Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.

Treatment and study plan

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.

Primary outcomes

Occurrence of adverse events

Time frame: During and after Ultravist application on the day of examination

Secondary outcomes

General contrast quality in the region of interest as assessed by physicians

Time frame: On the day of examination

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: IMAGE

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 6, 2009
Registry last updated: Feb 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed