A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports

August 26, 2022 updated by: Perouse Medical

This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.

The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 41500
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population was defined in the protocol as all patients who did receive POLYSITE® or SEESITE® device between 1st October 2016 and 31 December 2017.

Any patient who has disagreed with the collection of their personal data would be excluded from this study.

Description

Inclusion Criteria:

  • Adult and pediatric population
  • Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017

Exclusion Criteria:

  • Patient who refused the data collection according to RGPD regulation applicable in France
  • Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
  • Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of veins selected
Time Frame: 30 days
insertion's location of the POLYSITE®/SEESITE® implantable port
30 days
rate of peri-operative complication
Time Frame: Peri-operative procedure
number of complications between the implantation of the device and the first use (as example infections related to manipulation)
Peri-operative procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
type of treatments administered
Time Frame: 5 years
chemotherapy, antibiotics, parenteral nutrition, other
5 years
Rate of procedural success
Time Frame: Peri-operative procedure
correct placement and correct flow both confirmed by a radiological exam or an echography or an ECG.
Peri-operative procedure
short-term complication
Time Frame: 30 Days
number of complications: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain, and mechanical dysfunction (catheter fracture, occlusion, and port-pocket dehiscence, pinch-off, embolization, leak, port/catheter disconnection
30 Days
rate of long-term complications
Time Frame: 5 years
number of complications after 30 days of the implantation surgery up to the end of the follow-up: infections, inflammation, skin disorders, catheter-related venous thrombosis, mechanical dysfunction as occlusion/rupture/fracture/disconnection of the catheter, drug extravasation, mal-position, flip-over, migration, pinch-off.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perouse Medical

Collaborators

Eclevar Medtech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 14, 2021

Primary Completion (ACTUAL)

May 19, 2022

Study Completion (ACTUAL)

May 19, 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-MONO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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