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Not yet recruiting NCT07156123

PD Catheter Data Collection

— Observational Renal Insufficiency / Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Renal Insufficiency / Therapy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
  • Safety variables [Time frame: Every 6 months (± 2 months, as per centre practice)]
Secondary outcome measures (6)
  • Performance variables [Time frame: very 6 months (± 2 months, as per centre practice)]
  • Performance variables [Time frame: very 6 months (± 2 months, as per centre practice)]
  • Outcome variables [Time frame: very 6 months (± 2 months, as per centre practice)]
  • Outcome variables [Time frame: very 6 months (± 2 months, as per centre practice)]
  • Outcome variables [Time frame: very 6 months (± 2 months, as per centre practice)]
  • Outcome variables [Time frame: very 6 months (± 2 months, as per centre practice)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Klinikum Dortmund gGmbH — Dortmund

Identifiers

NCT: NCT07156123 · PD-Cathether-01-INT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗