PD Catheter Data Collection

Not yet recruiting

• Conditions: Renal Insufficiency / Therapy

• Registration Number: NCT07156123
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-12-01
• Primary Completion: 2029-06
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety variables	Every 6 months (± 2 months, as per centre practice)	Catheter removal

Secondary Outcome Measures

Name	Time	Method
Performance variables	very 6 months (± 2 months, as per centre practice)	Non-infectious complication
Outcome variables	very 6 months (± 2 months, as per centre practice)	Therapy tolerability.