The observational Post-Market Clinical Follow-up activity with the dialysis catheters P-DLS from Joline GmbH & Co.KG.
- Conditions
- N17N18Acute renal failureChronic kidney disease
- Registration Number
- DRKS00030687
- Lead Sponsor
- Joline GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
Clinical indication for extracorporeal blood purification and therefore the need for temporary vascular access.
-Decision of the physician to use the CE-marked dialysis catheter ST (P-DLS) according to the indications written in the instructions for use.
-A signed informed consent form
Exclusion Criteria
Patients with contraindications according to the instructions for use.
-occluded or thrombosed vessels
-Known allergic disposition to the material of the dialysis catheter
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the PMCF activity is to confirm the safety, performance and benefit of the CE-marked paediatric ST dialysis catheters when used in clinical routine within the indication according to the instructions for use.
- Secondary Outcome Measures
Name Time Method not applicable