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NCT Number: NCT05519787

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

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.

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Key information

Conditions

Venous System Antibiotics Antiviral Chemotherapy Hyperphagia Parenteral Nutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Transfusion Blood Venous Access

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR d'Orléans

Orléans, 41500, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Central Veinous access devices' insertion

Device

Medical doctor should complete a questionnaire with medical history or any important clinical data that could help for the selection of the location of the port and catheter placement. The insertion will be planned only by a surgeon, interventional radiologist, or anaesthesiologist in the surgery block.

For the patient with a medical history of PICC line, PAC implantation, Central venous access device of any kind, or clinical risk of veinous compression (cervical or subclavian adenopathy, pelerine syndrome, mediastinal involvement…). An echo Doppler exam of the veinous cervical system is required before surgery. This exam should identify potential thrombosis that required a special treatment. It is important that the surgeon who will perform the device's insertion is aware of any history or risks of veinous thrombosis, stenosis, or phlebitis for the patient to avoid procedure's failure.

Primary outcomes

  1. Identification of veins selected

    Time frame: 30 days

    insertion's location of the POLYSITE®/SEESITE® implantable port

  2. 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)

Secondary outcomes

  1. type of treatments administered

    Time frame: 5 years

    chemotherapy, antibiotics, parenteral nutrition, other

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Perouse Medical

Industry

Collaborators

  • Eclevar Medtech

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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