A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

Perouse Medical

Status: Enrolling

Conditions: Chemotherapy; Antibiotics; Antiviral Drugs; Blood Transfusion; Veinous; Parenteral Nutrition; Blood Derivatives Transfusion; PMCF Study

Treatments: Device: Implantation of veinous access ports

Study type: Observational

Funder types: Industry

Identifiers

NCT05519761

PSSS-2021-MULTI

Details and patient eligibility

About

The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics, antiviral drugs, parenteral nutrition, and for blood transfusion or blood derivatives transfusion.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult and paediatric population
• Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1-JAN-2018 and 31-DEC-2020

Exclusion criteria

• Patient who refused the data collection according to GDPR regulation applicable in France
• Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.