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

NCT05124821 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Michael Sasse, Dr. med. · Hannover Medical School

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2024-04-22
Completion
2024-04-22

Countries

  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05124821 on ClinicalTrials.gov