Clinical trial · Observational
PMCF Study of the CE-marked Drainova® ArgentiC Catheter
Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ascites | — | UNRESOLVED | — |
| Ascites, Malignant | — | UNRESOLVED | — |
| Pleural Effusion | — | UNRESOLVED | — |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indwelling catheter | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Ascites- and pleural effusion-associated symptom relief
- timeFrame
- Discharge (1-7 days post-implantation)
- description
- Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).
- measure
- Catheter patency
- timeFrame
- Discharge (1-7 days post-implantation)
- description
- Occurrence of catheter blockage, occlusion or displacement
- measure
- Implantation success
- timeFrame
- Immediately after procedure
- description
- Must meet the following items: 1. Successful placement at the defined location 2. Feasibility of initial drainage of fluid (volume in ml)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available