The Performance / Safety of the Celsite® Venous Access Ports
Conditions
Brief summary
The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion. The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.
Interventions
DEVICEVenous access port implantation
Venous access port implantation
Sponsors
B.Braun Médical - CoE Chasseneuil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patient is at least 18 years old * Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations. * Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU. * Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
Exclusion criteria
* Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU. * Patient not followed-up in the center where the access port is implanted. * Pregnancy * Patient \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the device's safety | 2 years | The primary variable is the incidence/frequency of all adverse reactions/complications (intraoperative, postoperative, late etc.) which occurred during the study. Focus will be done on all adverse reactions/complications (intraoperative, postoperative, late etc.) related to the Celsite® access ports written in the IFU in comparison with the published data. |
Outcome results
None listed