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

NCT05519787 | Completed

• 1 other identifier: PSSS-2021-MONO
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous System; Venous Access; Chemotherapy; Antibiotics; Antiviral; Parenteral Nutrition; Transfusion Blood

Outcome Measures

Primary Outcomes (2)

• Identification of veins selected

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

  30 days

• rate of peri-operative complication

  number of complications between the implantation of the device and the first use (as example infections related to manipulation)

  Peri-operative procedure

Secondary Outcomes (4)

• type of treatments administered

  5 years

• Rate of procedural success

  Peri-operative procedure

• short-term complication

  30 Days

• rate of long-term complications

  5 years

Interventions

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perouse Medical: lead
• Eclevar Medtech: collaborator

Study Sites (1)

CHR d'Orléans

Orléans, 41500, France

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: December 14, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

FR (1)