Status:
NOT_YET_RECRUITING
PD Catheter Data Collection
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Conditions:
Renal Insufficiency / Therapy
Eligibility:
All Genders
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07156123
Start Date
December 1 2025
End Date
June 1 2029
Last Update
September 4 2025
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