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| Name | Class |
|---|---|
| LS medcap GmbH | OTHER |
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indwelling catheter | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Discharge (1-7 days post-implantation) |
| Catheter patency | Occurrence of catheter blockage, occlusion or displacement | Discharge (1-7 days post-implantation) |
| Implantation success | Must meet the following items:
| 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 | Up to three months post-implanatation |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the patients´ quality-of-life vs. baseline | Quality-of-life will be assessed by QoL questionnaire | discharge (1-7 days post-implantation), 30 days, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any contraindication according to the IFU:
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Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.
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| Name | Affiliation | Role |
|---|---|---|
| Heidrun Steinle, Dr | LS medcap GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Augsburg | Augsburg | 86156 | Germany | |||
| Charité Universitätsmedizin Berlin |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D016066 | Pleural Effusion, Malignant |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002408 | Catheters, Indwelling |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Berlin |
| 10117 |
| Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09113 | Germany |
| Klinikum Chemnitz gGmbH MVZ Flemmingstraße | Chemnitz | 09116 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Asklepios Lungenklinik Gauting | Gauting | 82131 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Clemenshospital | Münster | 48153 | Germany |
| Krankenhaus Barmherzige Brüder | Regensburg | 93049 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |