The Performance / Safety of the Celsite® Venous Access Ports (CAP)

B. Braun

Status: Not yet enrolling

Conditions: The Performance / Safety of the Celsite® Venous Access Ports

Treatments: Device: Venous access port implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT05572112

AAG-0-H-2122

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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