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

Post Market Clinical Follow-up Study on the Performance /Safety of Celsite® Venous Access Ports in Patients Who Need Repeated Venous Access

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.

Study Overview

• Status: Not yet recruiting
• Conditions: The Performance / Safety of the Celsite® Venous Access Ports
• Intervention / Treatment: Device: Venous access port implantation

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient is at least 18 years old

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the device's safety	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.	2 years

Collaborators and Investigators

• Sponsor: B.Braun Médical - CoE Chasseneuil

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): January 30, 2025

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AAG-0-H-2122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No