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

Study Overview
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Brief Summary
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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.

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

Conditions
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Venous System, Venous Access, Chemotherapy, Antibiotics, Antiviral, Parenteral Nutrition, Transfusion Blood

Intervention / Treatment
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* Device: Central Veinous access devices' insertion


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Central 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of veins selected | insertion's location of the POLYSITE®/SEESITE® implantable port | 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) | Peri-operative procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of treatments administered | chemotherapy, antibiotics, parenteral nutrition, other | 5 years | 
| Rate of procedural success | correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG. | 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 | 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. | 5 years |