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

February 25, 2011 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44920

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: During and after Ultravist application on the day of examination
During and after Ultravist application on the day of examination

Secondary Outcome Measures

Outcome Measure
Time Frame
General contrast quality in the region of interest as assessed by physicians
Time Frame: On the day of examination
On the day of examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 14692
  • 13859
  • 13421
  • 14338
  • UV0701
  • 13422
  • 14480
  • 13276
  • 14336
  • 14181
  • 13602
  • 14243
  • 13275
  • 14180
  • 14376
  • 14337
  • 14245
  • 13212
  • 14526
  • 14527
  • 14528
  • 14586
  • 14661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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