PD Catheter Data Collection
ConditionRenal Insufficiency / Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFresenius Medical Care Deutschland GmbH
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
300 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov