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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519761 on ClinicalTrials.gov