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NCT Number: NCT06436807

PMCF Study 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.

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Key information

Conditions

Pleural Effusion Ascites Ascites, Malignant Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Augsburg, Augsburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indwelling Catheter

Device

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.

Primary outcomes

  1. 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).

  2. Catheter patency

    Time frame: Discharge (1-7 days post-implantation)

    Occurrence of catheter blockage, occlusion or displacement

  3. Implantation success

    Time frame: Immediately after procedure

    Must meet the following items:

    • Successful placement at the defined location
    • Feasibility of initial drainage of fluid (volume in ml)

  4. 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

Secondary outcomes

  1. Improvement of the patients´ quality-of-life vs. baseline

    Time frame: discharge (1-7 days post-implantation), 30 days, 3 months

    Quality-of-life will be assessed by QoL questionnaire

Sponsors and collaborators

Lead sponsor

ewimed GmbH

Industry

Collaborators

  • LS medcap GmbH

Registry information

Official study title

Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 31, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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