A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

Perouse Medical

Status: Completed

Conditions: Transfusion Blood; Antiviral; Chemotherapy; Antibiotics; Venous System; Parenteral Nutrition; Venous Access

Treatments: Device: Central Veinous access devices' insertion

Study type: Observational

Funder types: Industry

Identifiers

NCT05519787

PSSS-2021-MONO

Details and patient eligibility

About

This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.

The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult and pediatric population
• Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017

Exclusion criteria

• Patient who refused the data collection according to RGPD regulation applicable in France
• Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
• Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017