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

Completed

• Conditions: Venous Access; Antibiotics; Antiviral; Venous System; Chemotherapy; Parenteral Nutrition; Transfusion Blood

• Registration Number: NCT05519787
• Lead Sponsor: Perouse Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-14
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-26
• Study First Posted: 2022-08-29
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
type of treatments administered	5 years	chemotherapy, antibiotics, parenteral nutrition, other

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France