The observational Post-Market Clinical Follow-up activity with the dialysis catheters LT from Joline GmbH & Co.KG
- Conditions
- N17Acute renal failure
- Registration Number
- DRKS00027404
- Lead Sponsor
- Joline GmbH & Co. KG
- Brief Summary
Clinical data of the long-term (LT) Dialysis Catheter family: PU-LT and Silicone-LT (including the Single Lumen (ISK) and Double Lumen retrograde (R-IDLK) variants) were collected during an observative device registry/ Post-Market Clinical Follow-up (PMCF) activity. The anterograde tunneled Dialysis Catheter PU-LT variant, branded Smooth Flow Double Lumen LT, has been commercially available since 2011, and the retrograde tunneled Dialysis Catheter PU-LT variant, branded Evolution Flow Double Lumen LT, has been available on the market since 2019. The anterograde and retrograde tunneled Dialysis Catheter Silicone LT have been commercially available since 2002. They are intended to provide long-term venous vascular access for performing extracorporeal blood purification procedures. The outcome variables with regard to safety were chosen to be the frequency of total major adverse events, severe major adverse events (MAEs) and device malfunctions as well as the assessment of safety-relevant variables of device handling and intended use. The outcome variables regarding performance of the Dialysis Catheter LT were catheter placement success and technical performance success. As the clinical benefit describes, the direct or indirect positive impact of a device on the health of a patient, the outcome variables with regard to clinical benefit were chosen to be the frequency of product-related implantation complications, catheter-associated infections and infection-associated explantations. The activity was completed in Q2 2023 and in total 250 patients for the PU-LT variants and 238 patients for the Silicone LT variants are included. Performance of the device was evaluated based on different factors meaning successful catheter placement (93.6% for PU-LT and 94.12% for Si-LT) and technical performance success (84.4% for PU-LT and 83.61% for Si-LT). The device deficiency-free rate (meaning: complications related to the catheter itself) was 100% for PU-LT and the frequency of severe complications (MAEs) was 2.4%. The device deficiency-free rate was 100% and 99.17% for the Single Lumen (ISK) and the Double Lumen retrograde (R-IDLK), respectively and the frequency of severe complications was 0.84%. Thereby, the safety of the device variants was confirmed. The clinical benefit of the Dialysis Catheter LT was evaluated and confirmed based on the low frequencies of product-related complications, catheter-associated infections and infection-associated catheter explantations (meaning the removal of the catheter because of an infection with the catheter). For the PU-LT, the frequency of product-related complications, catheter-associated infections and infection-associated explantations was 0%, 11.2% and 2.8%, respectively. For the Silicone LT, the frequency of product-related complications, catheter-associated infections and infection-associated explantations was 0.42%, 8.4% and 1.68%, respectively. The acceptance criteria for clinical benefit, established to be the sum of the frequency of the product-related complications and catheter-associated infections being below 30%, were met. This Post-Market Clinical Follow-up activity revealed low complication and adverse event rates, with no previously unknown side-effects, contraindications, emergent risks or potential misuse/ off-label use for the Dialysis Catheter Silicone LT. Since safety, performance and clinical benefit have been demonstrated for the Dialysis Catheter LT, the clinical evaluation revealed that there are no known uncertainties regarding safety and performance of the Dialysis Catheter LT. It can be concluded that any residual risks and undesirable side-effects, which may be associated with the intended use of the Dialysis Catheter Silicone LT constitute acceptable risks when weighed against the benefits to the patient, given the severity of the disease and the consequences that arise from the lack of renal replacement therapies (including death of the patient).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 488
use of a CE-marked dialysis catheters LT from the Joline GmbH according to the described indications in the IFU
- signed informed and data protection consent form
- Patients with any contraindication according to the IF
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of the PMCF activity is to assess safety, performance, and benefit of the CE-marked long-term dialysis catheters used in clincial routine within their indication according to the IFU.
- Secondary Outcome Measures
Name Time Method ot applicable.