Observational study of the Drainova® ArgentiC Catheter for treating fluid accumulations
Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
ewimed GmbH · NCT06436807
This study is testing how well the Drainova® ArgentiC Catheter works for people with fluid build-up in their bodies, like in pleural effusions and ascites, to see if it helps relieve their symptoms and is safe to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ewimed GmbH (industry) |
| Locations | 12 sites (Augsburg and 11 other locations) |
| Trial ID | NCT06436807 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance of the Drainova® ArgentiC Catheter, which is used to manage fluid accumulations in hollow body structures, specifically for pleural effusions and ascites. Participants will receive the catheter as part of their standard treatment, and the study will assess whether the device functions as intended, identifies any unrecognized safety risks, and evaluates its effectiveness in alleviating patient symptoms. Data will be collected through patient and physician feedback regarding symptom improvement and any complications related to the catheter.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who can provide informed consent and require treatment for pleural effusions or ascites.
Not a fit: Patients with contraindications such as coagulopathy, infections in the body cavity, or known allergies to materials used in the catheter may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could confirm the safety and effectiveness of the Drainova® ArgentiC Catheter, potentially improving treatment outcomes for patients with fluid accumulations.
How similar studies have performed: While this study is observational and focuses on an already CE-marked device, similar studies have previously demonstrated the effectiveness of catheter-based interventions for fluid management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augsburg and 11 other locations
- Universitätsklinikum Augsburg — Augsburg, Germany (RECRUITING)
- Charité Universitätsmedizin Berlin — Berlin, Germany (RECRUITING)
- Klinikum Chemnitz gGmbH — Chemnitz, Germany (RECRUITING)
- Klinikum Chemnitz gGmbH MVZ Flemmingstraße — Chemnitz, Germany (RECRUITING)
- Universitätsklinikum Freiburg — Freiburg, Germany (RECRUITING)
- Universitätsklinikum Freiburg — Freiburg, Germany (RECRUITING)
- Medizinische Hochschule Hannover — Hannover, Germany (RECRUITING)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (RECRUITING)
- Lungenklinik Hemer — Hemer, Germany (RECRUITING)
- Clemenshospital — Münster, Germany (RECRUITING)
- Krankenhaus Barmherzige Brüder — Regensburg, Germany (RECRUITING)
- Universitätsklinikum Regensburg — Regensburg, Germany (RECRUITING)
Study contacts
- Study coordinator: Natasa Mitrovic, MSc
- Email: natasa.mitrovic@lsmedcap.com
- Phone: +49 7471 9849 9529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pleural Effusion, Pleural Effusion, Malignant, Ascites, Ascites, Malignant