non interventional study with VISIPAQUE™ 270/320.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005352

Enrollment

14500

Registered

2014-04-29

Start date

2013-09-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Indication for performing a CT examination using Visipaque

Interventions

Group 1: data on the radiation dose, X-ray constrast agent dose as well as influence parameters are collected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: non-interventional study, no influence of physicians patient selection by inclusion or exclusion criteria; Treatment according to the current SmPc

Exclusion criteria

Exclusion criteria: non-interventional study, no influence of physicians patient selection by inclusion or exclusion criteria; Treatment according to the current SmPc

Design outcomes

Primary

Measure	Time frame
The primary endpoints are the frequencies of investigations with a low dose of radiation and / or a low dose of X-ray contrast agent dose in general, and per indication. The frequency of these low-dose studies is further examined using a logistic regression model. The basic model includes the variables "iterative and / or model-based image reconstruction (yes / no)" and "applied tube voltage = 100 kVp (yes / no)". Additional models are specifically charged with parameters include (eg, patient's age, experience of the physician, indication of the study, sex of the examiner).	—

Measure

Time frame

The primary endpoints are the frequencies of investigations with a low dose of radiation and / or a low dose of X-ray contrast agent dose in general, and per indication. The frequency of these low-dose studies is further examined using a logistic regression model. The basic model includes the variables "iterative and / or model-based image reconstruction (yes / no)" and "applied tube voltage = 100 kVp (yes / no)". Additional models are specifically charged with parameters include (eg, patient's age, experience of the physician, indication of the study, sex of the examiner).

—

Secondary

Measure	Time frame
Secondary endpoints are the frequencies of image qualities in terms of confidence in the diagnosis (absent / poor / fair / good / excellent). The frequencies for each class image quality is analyzed using a logistic regression model. The basic model includes the variables "iterative and / or model-based image reconstruction (yes / no)" and "applied tube voltage = 100 kVp (yes / no)". Additional models are specifically charged with parameters include (eg, patient's age, weight, experience of the examiner, the indication for the study, Visipaque ™ dose (volume and / or iodine).	—

Measure

Time frame

Secondary endpoints are the frequencies of image qualities in terms of confidence in the diagnosis (absent / poor / fair / good / excellent). The frequencies for each class image quality is analyzed using a logistic regression model. The basic model includes the variables "iterative and / or model-based image reconstruction (yes / no)" and "applied tube voltage = 100 kVp (yes / no)". Additional models are specifically charged with parameters include (eg, patient's age, weight, experience of the examiner, the indication for the study, Visipaque ™ dose (volume and / or iodine).

—

Countries

Germany

Contacts

Public ContactBarbara Zorn

GE Healthcare & Buchler GmbH & Co. KG

barbara.zorn@ge.com089 96281-327

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026