Antibiotics, Antiviral, Chemotherapy, Parenteral Nutrition, Transfusion Blood, Venous Access, Venous System
Conditions
Brief summary
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.
Interventions
DEVICECentral Veinous access devices' insertion
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.
Sponsors
Eclevar Medtech
Perouse Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of veins selected | 30 days | insertion's location of the POLYSITE®/SEESITE® implantable port |
| rate of peri-operative complication | Peri-operative procedure | number of complications between the implantation of the device and the first use (as example infections related to manipulation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| type of treatments administered | 5 years | chemotherapy, antibiotics, parenteral nutrition, other |
| Rate of procedural success | Peri-operative procedure | correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG. |
| short-term complication | 30 Days | 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 |
| rate of long-term complications | 5 years | 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. |
Countries
France
Outcome results
None listed