The Performance / Safety of the Celsite® Venous Access Ports

NCT05572112 | Unknown

• 1 other identifier: AAG-0-H-2122
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

The Performance / Safety of the Celsite® Venous Access Ports

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Venous access port implantation DEVICE

Venous access port implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient is at least 18 years old

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.Braun Médical - CoE Chasseneuil: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 15, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2025
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share