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NCT Number: NCT07156123

PD Catheter Data Collection

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Dortmund gGmbH

Dortmund, 44137, Germany

Location contact

Fedai Özcan, Dr. med.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)

  2. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Non-infectious complications

  3. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Biocompatibility (allergic reaction)

  4. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Identify new emerging risks

  5. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Monitor side effects

  6. Safety variables

    Time frame: Every 6 months (± 2 months, as per centre practice)

    Catheter removal

Secondary outcomes

  1. Performance variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Catheter patency

  2. Performance variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Non-infectious complication

  3. Outcome variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Peritoneal clearance

  4. Outcome variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Peritoneal UF

  5. Outcome variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Mechanical complications

  6. Outcome variables

    Time frame: very 6 months (± 2 months, as per centre practice)

    Therapy tolerability.

Study contacts

Contact information is provided by the study sponsor or research team.

Celina Meyer

CONTACT

[email protected]

+49 6172 268 6809

Fiona Bellando

CONTACT

[email protected]

+49 6172 8868776

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

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

Acronym: Catheter

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 4, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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