PMCF Study of the CE-marked Drainova® ArgentiC Catheter
- Conditions
- Pleural Effusion, MalignantAscitesAscites, MalignantPleural Effusion
- Registration Number
- NCT06436807
- Lead Sponsor
- ewimed GmbH
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
- Patients ≥ 18 years old
- Patients being able to give informed consent
Patients with any contraindication according to the IFU:
- presence of septa in the body cavity
- coagulopathy
- infection in the body cavity
- lymphatic effusion
- shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
- known allergies to any of the materials used in the drainage product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of major adverse events, infections and device deficiencies Up to three months post-implanatation Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies
Ascites- and pleural effusion-associated symptom relief Discharge (1-7 days post-implantation) Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).
Catheter patency Discharge (1-7 days post-implantation) Occurrence of catheter blockage, occlusion or displacement
Implantation success Immediately after procedure Must meet the following items:
1. Successful placement at the defined location
2. Feasibility of initial drainage of fluid (volume in ml)
- Secondary Outcome Measures
Name Time Method Improvement of the patients´ quality-of-life vs. baseline discharge (1-7 days post-implantation), 30 days, 3 months Quality-of-life will be assessed by QoL questionnaire
Trial Locations
- Locations (11)
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Klinikum Chemnitz gGmbH MVZ Flemmingstraße
🇩🇪Chemnitz, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Lungenklinik Hemer
🇩🇪Hemer, Germany
Clemenshospital
🇩🇪Münster, Germany
Krankenhaus Barmherzige Brüder
🇩🇪Regensburg, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany