NCT05124821

Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

Summary

Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.

Conditions

• Central Venous Catheter

Interventions

Type	Name	Description
DEVICE	Central venous catheter intended to be used for children during routine clinical practice	Device will applied according to instruction for use (IFU) and respective indication during routine clinical practice.

Timeline

• Start date: 2023-05-19
• Primary completion: 2024-04-22
• Completion: 2024-04-22
• First posted: 2021-11-18
• Last updated: 2024-06-13

Locations

3 sites across 2 countries: Germany, Italy