PD Catheter Data Collection

Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07156123

Acronym

Catheter

Enrollment

300

Registered

2025-09-04

Start date

2026-07-03

Completion date

2029-12-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency / Therapy

Keywords

Peritoneal dialysis, Renal replacement therapy, Ultrafiltration, Catheter

Brief summary

Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety variables	Every 6 months (± 2 months, as per centre practice)	Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)

Secondary

Measure	Time frame	Description
Performance variables	very 6 months (± 2 months, as per centre practice)	Catheter patency
Outcome variables	very 6 months (± 2 months, as per centre practice)	Peritoneal clearance

Countries

Germany

Contacts

CONTACTFiona Bellando

fiona.bellando@freseniusmedicalcare.com+49 6172 8868776

CONTACTCelina Meyer

celina.meyer@freseniusmedicalcare.com+49 6172 268 6809

PRINCIPAL_INVESTIGATORFedai Özcan, Dr. med.

Klinikum Dortmund Wirbelsäulenchirurgie

Outcome results