Ascites, Ascites, Malignant, Pleural Effusion, Pleural Effusion, Malignant
Conditions
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.
Interventions
DEVICEIndwelling catheter
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.
Sponsors
ewimed GmbH
LS medcap GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Patients being able to give informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
STUDY_CHAIRHeidrun Steinle, Dr
LS medcap GmbH
Outcome results
None listed