A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
NCT05519761 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2022-08-29
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.
Conditions
- Veinous
- Chemotherapy
- Antibiotics
- Antiviral Drugs
- Parenteral Nutrition
- Blood Transfusion
- Blood Derivatives Transfusion
- PMCF Study
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Eclevar Medtech
collaborator INDUSTRY -
Perouse Medical
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-15
- Primary Completion
- 2022-10-30
- Completion
- 2022-10-30
Countries
- France
Study Locations
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