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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Veinous Chemotherapy Antibiotics Antiviral Drugs Parenteral Nutrition Blood Transfusion Blood Derivatives Transfusion PMCF Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Implantation 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No