PMCF Study of the CE-marked Drainova® ArgentiC Catheter

Last updated: March 10, 2026
Sponsor: ewimed GmbH
Overall Status: Completed

Phase

N/A

Condition

Liver Disease

Lung Disease

Pleural Effusion

Treatment

Indwelling catheter

Clinical Study ID

NCT06436807
23-079
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years old

  • Patients being able to give informed consent

Exclusion

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 pleuraleffusion)

  • known allergies to any of the materials used in the drainage product

Study Design

Total Participants: 169
Treatment Group(s): 1
Primary Treatment: Indwelling catheter
Phase:
Study Start date:
June 26, 2024
Estimated Completion Date:
January 09, 2026

Study 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.

Connect with a study center

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH MVZ Flemmingstraße

    Chemnitz, 09116
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106
    Germany

    Site Not Available

  • Asklepios Lungenklinik Gauting

    Gauting, 82131
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hanover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69126
    Germany

    Site Not Available

  • Lungenklinik Hemer

    Hemer, 58675
    Germany

    Site Not Available

  • Clemenshospital

    Münster, 48153
    Germany

    Site Not Available

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

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