The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment. The main questions of this study are: * Does the device function as intended? * Are there any other safety risks that have not been identified? * Does it lower the symptoms of the patients as intended? Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.
The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU). This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.
Study Type
OBSERVATIONAL
Enrollment
162
The tunneled catheter is an implant product that enables the drainage of effusion accumulations from serous body cavities so that the symptoms caused by an effusion are relieved by draining off the accumulated fluids.
Universitätsklinikum Augsburg
Augsburg, Germany
RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGKlinikum Chemnitz gGmbH
Chemnitz, Germany
RECRUITINGKlinikum Chemnitz gGmbH MVZ Flemmingstraße
Chemnitz, Germany
RECRUITINGUniversitätsklinikum Freiburg
Freiburg im Breisgau, Germany
RECRUITINGUniversitätsklinikum Freiburg
Freiburg im Breisgau, Germany
RECRUITINGMedizinische Hochschule Hannover
Hanover, Germany
RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGLungenklinik Hemer
Hemer, Germany
RECRUITINGClemenshospital
Münster, Germany
RECRUITING...and 2 more locations
Ascites- and pleural effusion-associated symptom relief
Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).
Time frame: Discharge (1-7 days post-implantation)
Catheter patency
Occurrence of catheter blockage, occlusion or displacement
Time frame: Discharge (1-7 days post-implantation)
Implantation success
Must meet the following items: 1. Successful placement at the defined location 2. Feasibility of initial drainage of fluid (volume in ml)
Time frame: Immediately after procedure
Incidence of major adverse events, infections and device deficiencies
Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies
Time frame: Up to three months post-implanatation
Improvement of the patients´ quality-of-life vs. baseline
Quality-of-life will be assessed by QoL questionnaire
Time frame: discharge (1-7 days post-implantation), 30 days, 3 months
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