A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
NCT ID: NCT05519787
Last Updated: 2022-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2021-12-14
2022-05-19
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Central Veinous access devices' insertion
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
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Eclevar Medtech
INDUSTRY
Perouse Medical
INDUSTRY
Responsible Party
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Locations
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CHR d'Orléans
Orléans, , France
Countries
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Other Identifiers
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PSSS-2021-MONO
Identifier Type: -
Identifier Source: org_study_id
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