NCT05519787

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Perouse Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Venous System
• Venous Access
• Chemotherapy
• Antibiotics
• Antiviral
• Parenteral Nutrition
• Transfusion Blood

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2022-08-29
• Last updated: 2022-08-29

Locations

1 site across 1 country: France