Antibiotics, Antiviral Drugs, Blood Derivatives Transfusion, Blood Transfusion, Chemotherapy, Parenteral Nutrition, PMCF Study, Veinous
Conditions
Brief summary
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.
Interventions
DEVICEImplantation of veinous access ports
The surgeon, anaesthetist and interventional radiologist should be thoroughly familiar with the surgical procedure, instruments, and device characteristics prior to performing the implantation. The nurse has also to be familiar with the implantable port since he/she intervenes in it at the time of the Huber needle puncture and solution injection.
Sponsors
Eclevar Medtech
Perouse Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Associate Performance : correct device insertion assess Clinical endpoint | Peri-procedure | percentage of patients with correct placement objectively assessed by clinical observation |
| Performance : success of the insertion and placement of the implantable port. | Peri-procedure | evaluation of the success of the insertion and placement of the implantable port. |
| Associate Performance : correct device insertion assess by Radiological endpoint | Peri-procedure | percentage of patients with correct insertion into venous access objectively assessed via radiography, ECG or echography measurement |
| Per-procedure Safety | 30 Days | evaluation of the safety of the implantable ports |
| Associated Safety : rate of complications | 30 days | measurement of the rate of complications reported during the short-term period of 30 days after the implantation date. As example, the following short-term complications will be looked at: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Long Term period: complications | 5 years | measurement of the rate of complications reported during the whole study and at the defined study timepoints. As example, the following long-term complications will be looked at: infections, inflammation, skin disorders, catheter-related venous thrombosis, pinch-off. |
| Performance : evaluation of the device performance | 5 years | percentage of patients with correct device insertion by the general surgeon, anaesthetist, or the radiologist. The insertion could be done under Echo or under fluoroscopy or ECG |
| Emergent Risks | 5 years | AEs collection |
| device failure | 5 years | measurement of the rate of device failure throughout the study until the device is removed from the patient's body. The device failures are defined as mechanical dysfunctions (catheter fracture, occlusion, and port-pocket dehiscence, pinch-off, embolization, leak, port/catheter disconnection, drug extravasation, mal-position, flip-over, migration, local venous thrombosis, etc…). |
| Safety: perioperative time | 5 years | duration between the implantation procedure and the first use of the implantable port |
| Safety FU period: Device Failure Removal | 5 years | the complications will be followed up to 30 days after the implantable port removal. If the removal is related to a device failure or a complication related to the device, the patient's safety will be followed until the resolution of the complication.the complications will be followed up to 30 days after the implantable port removal. If the removal is related to a device failure or a complication related to the device, the patient's safety will be followed until the resolution of the complication. |
| Safety Long Term period: Device Failure Removal | 5 years | the complications will be followed up to 30 days after the implantable duration starting after the first 30 days after the implantation procedure and up to device removal, or patient death, or lost to follow-up, depending on what event comes first in the patient's medical chart. Study timepoints have been defined as 6-months Follow-up after the Implantation procedure, 12-months Follow-up after the Implantation procedure, 24-months Followup after the Implantation procedure and 36-months Follow-up after the Implantation procedure. |
Countries
France
Contacts
Primary ContactChems Hachani, CEO
Outcome results
None listed