PMCF Study of the CE-marked Drainova® ArgentiC Catheter

Last updated: February 27, 2025
Sponsor: ewimed GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Liver 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: 162
Treatment Group(s): 1
Primary Treatment: Indwelling catheter
Phase:
Study Start date:
June 26, 2024
Estimated Completion Date:
August 31, 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

    Active - Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH MVZ Flemmingstraße

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • Lungenklinik Hemer

    Hemer, 58675
    Germany

    Active - Recruiting

  • Clemenshospital

    Münster, 48153
    Germany

    Active - Recruiting

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049
    Germany

    Active - Recruiting

  • Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.