Pleural EffusionNCT06436807
PMCF Study of the CE-marked Drainova® ArgentiC Catheter
An observational study of Pleural Effusion and Pleural Effusion, Malignant, run by ewimed GmbH at 12 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pleural Effusion, Malignant, Ascites
- What is being tested?
- Indwelling catheter
- Type of treatment
- Medical device
- How many people
- 169 participants
- Where
- 12 sitesGermany
- Study dates
- 26 Jun 2024to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.
Who may be able to join
- Patients ≥ 18 years old
- Patients being able to give informed consent
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Universitätsklinikum Augsburg
Augsburg, 86156
Charité Universitätsmedizin Berlin
Berlin, 10117
Klinikum Chemnitz gGmbH
Chemnitz, 09113
Klinikum Chemnitz gGmbH MVZ Flemmingstraße
Chemnitz, 09116
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Asklepios Lungenklinik Gauting
Gauting, 82131
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Heidelberg
Heidelberg, 69126
Lungenklinik Hemer
Hemer, 58675
Clemenshospital
Münster, 48153
Krankenhaus Barmherzige Brüder
Regensburg, 93049
Universitätsklinikum Regensburg
Regensburg, 93053
About this study
Official title: Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
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.
Read the 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.
- Being tested
- Indwelling catheter
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling catheterDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Discharge (1-7 days post-implantation)
Catheter patency
Occurrence of catheter blockage, occlusion or displacement
Measured: Discharge (1-7 days post-implantation)
Implantation success
Must meet the following items:
- Successful placement at the defined location
- Feasibility of initial drainage of fluid (volume in ml)
Measured: 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
Measured: Up to three months post-implanatation
Secondary outcomes (1)
Improvement of the patients´ quality-of-life vs. baseline
Quality-of-life will be assessed by QoL questionnaire
Measured: discharge (1-7 days post-implantation), 30 days, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start26 Jun 2024
- Primary completion14 Oct 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- ewimed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LS medcap GmbH
- Responsible party
- Sponsor
- Investigators
- Heidrun Steinle, Dr, Study chair, LS medcap GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436807
- Sponsor's protocol ID
- 23-079
- Status last verified
- Mar 2026
- First submitted
- 15 May 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
- ClinicalTrials.gov ID
- NCT06436807
- Acronym / sponsor ID
- 23-079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- ewimed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LS medcap GmbH
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old
- Patients being able to give informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indwelling catheterThe 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. | Device | – |
Primary outcome
Ascites- and pleural effusion-associated symptom relief
Time frame: 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
Time frame: Discharge (1-7 days post-implantation)
Occurrence of catheter blockage, occlusion or displacement
Implantation success
Time frame: 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
Time frame: Up to three months post-implanatation
Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies
1 secondary outcome
Improvement of the patients´ quality-of-life vs. baseline
Time frame: discharge (1-7 days post-implantation), 30 days, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidrun Steinle, Dr study chair
LS medcap GmbH
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Pleural Effusion, Malignant, run by ewimed GmbH at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascites- and pleural effusion-associated symptom relief (time frame: Discharge (1-7 days post-implantation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.