A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

• Conditions: Chemotherapy; Parenteral Nutrition; Blood Derivatives Transfusion; PMCF Study; Veinous; Blood Transfusion; Antibiotics; Antiviral Drugs

• Registration Number: NCT05519761
• Lead Sponsor: Perouse Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• 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
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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 Clinical endpoint	Peri-procedure	percentage of patients with correct placement objectively assessed by clinical observation
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 Outcome Measures

Name	Time	Method
Safety: perioperative time	5 years	duration between the implantation procedure and the first use of the implantable port
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
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 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.
Emergent Risks	5 years	AEs collection

Trial Locations

Locations (3)

Hopital Foch; 🇫🇷 Suresnes, France

CHR d'Orléans; 🇫🇷 Orléans, France

IGR; 🇫🇷 Villejuif, France