Long-term use of Fresenius PD catheters in adults and kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data on patients who started using Fresenius Medical Care catheters for peritoneal dialysis within the last 18 months. It will analyze safety and performance, focusing on catheter function, peritoneal clearance, and ultrafiltration as treatment outcomes. Data will include both clinical outcomes and PD treatment parameters to characterize long-term catheter use in real-world settings. Participation requires informed consent from patients or guardians and is limited to those treated with CAPD or APD. No specific interventions are assigned; the study observes routine care to understand long-term experiences with these catheters.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed and dated informed consent for study participation and data submission (by the patient or legal representative for patients under 18) along with investigator/authorized physician signature.
* Patients under 18 who have received age- and maturity-appropriate information per Article 63(2) MDR from trained investigators or team members; minors capable of understanding must also sign the informed consent.
* The investigator must respect the decision of any minor, capable of understanding the information as per Article 63(2) MDR, to decline participation or withdraw from the clinical investigation at any time.
* Ability to understand the nature and requirements of the study.
* Patients with indication for renal replacement therapy, specifically PD (CAPD or APD)
* Patients who began PD using FME catheters within the last 18 months and are either prevalent in PD at study initiation or have switched to HD or undergone transplantation and can consent to data use.
* Incident patients who will begin PD using FME catheters.

Exclusion Criteria:

* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations,
* Previous participation in the same study.
* Life expectancy \< 3 months.

Where it's running

• Klinikum Dortmund gGmbH
  Dortmund, Germany Recruiting
• RCU- Renal Care Unit, Dr. med. Mario Gerrit Bohling
  Wilhelmshaven, Germany Recruiting

Study contacts

• Principal investigator: Fedai Özcan, Dr. med. — Klinikum Dortmund Wirbelsäulenchirurgie
• Study coordinator: Fiona Bellando
• Email: fiona.bellando@freseniusmedicalcare.com
• Phone: +49 6172 8868776

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.