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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy; Blood Transfusion; Antibiotics; Parenteral Nutrition; Antiviral Drugs; Veinous; Blood Derivatives Transfusion; PMCF Study
• Intervention / Treatment: Device: Implantation of veinous access ports

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Chems Hachani, CEO; Phone Number: 33 699150368; Email: chachani@eclevar.com

Study Locations

• France
  • Orléans, France, 45100
    • Recruiting
    • CHR d'Orléans
    • Contact: Adel Abou Mrad, MD
  • Suresnes, France, 92150
    • Recruiting
    • Hôpital Foch
    • Contact: Alexandre Valée, MD
  • Villejuif, France, 94805
    • Recruiting
    • IGR
    • Contact: Frédéric Gomas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All references of POLYSITE® and SEESITE® implantable ports apply to adult targeted population group.

Only POLYSITE® and SEESITE® implantable ports referenced as 2000 series (micro size) and connected to a 5F catheter apply to paediatric (>10 kg) targeted population groups.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance : success of the insertion and placement of the implantable port.	evaluation of the success of the insertion and placement of the implantable port.	Peri-procedure
Associate Performance : correct device insertion assess by Radiological endpoint	percentage of patients with correct insertion into venous access objectively assessed via radiography, ECG or echography measurement	Peri-procedure
Associate Performance : correct device insertion assess Clinical endpoint	percentage of patients with correct placement objectively assessed by clinical observation	Peri-procedure
Per-procedure Safety	evaluation of the safety of the implantable ports	30 Days
Associated Safety : rate of complications	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance : evaluation of the device performance	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	5 years
device failure	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…).	5 years
Safety: perioperative time	duration between the implantation procedure and the first use of the implantable port	5 years
Safety FU period: Device Failure Removal	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.	5 years
Safety Long Term period: Device Failure Removal	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.	5 years
Safety Long Term period: complications	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.	5 years
Emergent Risks	AEs collection	5 years

Collaborators and Investigators

• Sponsor: Perouse Medical
• Collaborators: Eclevar Medtech

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PSSS-2021-MULTI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No