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

N/ACompletedNCT05519787

Perouse Medical70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Venous System Venous Access Chemotherapy Antibiotics Antiviral Parenteral Nutrition Transfusion Blood

Central Veinous access devices' insertionDEVICE

Medical doctor should complete a questionnaire with medical history or any important clinical data that could help for the selection of the location of the port and catheter placement. The insertion will be planned only by a surgeon, interventional radiologist, or anaesthesiologist in the surgery block. For the patient with a medical history of PICC line, PAC implantation, Central venous access device of any kind, or clinical risk of veinous compression (cervical or subclavian adenopathy, pelerine syndrome, mediastinal involvement…). An echo Doppler exam of the veinous cervical system is required before surgery. This exam should identify potential thrombosis that required a special treatment. It is important that the surgeon who will perform the device's insertion is aware of any history or risks of veinous thrombosis, stenosis, or phlebitis for the patient to avoid procedure's failure.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Identification of veins selected

insertion's location of the POLYSITE®/SEESITE® implantable port

Time frame: 30 days

rate of peri-operative complication

number of complications between the implantation of the device and the first use (as example infections related to manipulation)

Time frame: Peri-operative procedure

Secondary Outcomes

type of treatments administered

chemotherapy, antibiotics, parenteral nutrition, other

Time frame: 5 years

Rate of procedural success

correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG.

Time frame: Peri-operative procedure

short-term complication

number of complications: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain, and mechanical dysfunction (catheter fracture, occlusion, and port-pocket dehiscence, pinch-off, embolization, leak, port/catheter disconnection

Time frame: 30 Days

rate of long-term complications

number of complications after 30 days of the implantation surgery up to the end of the follow-up: infections, inflammation, skin disorders, catheter-related venous thrombosis, mechanical dysfunction as occlusion/rupture/fracture/disconnection of the catheter, drug extravasation, mal-position, flip-over, migration, pinch-off.