PMCF Study of the CE-marked Drainova® ArgentiC Catheter
NCT ID: NCT06436807
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
162 participants
OBSERVATIONAL
2024-06-26
2026-08-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Indwelling catheter
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.
Eligibility Criteria
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Inclusion Criteria
* Patients being able to give informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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LS medcap GmbH
OTHER
ewimed GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Heidrun Steinle, Dr
Role: STUDY_CHAIR
LS medcap GmbH
Locations
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Universitätsklinikum Augsburg
Augsburg, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Klinikum Chemnitz gGmbH MVZ Flemmingstraße
Chemnitz, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Lungenklinik Hemer
Hemer, , Germany
Clemenshospital
Münster, , Germany
Krankenhaus Barmherzige Brüder
Regensburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Philipp Jawny
Role: primary
Jens-Carsten Rückert, Prof. Dr. med.
Role: primary
Sven Seifert, Dr. med.
Role: primary
Ilja Kubisch, Dr. med.
Role: primary
Michael Schultheiß, PD Dr. med.
Role: primary
Mirjam Elze, Dr. med.
Role: primary
Benjamin Maasoumy, Prof. Dr. med.
Role: primary
Hauke Winter, Prof. Dr. med.
Role: primary
Stefan Welter, PD Dr. med.
Role: primary
Peter Feindt, Prof. Dr. med.
Role: primary
Hans-Stefan Hofmann, Prof. Dr. med.
Role: primary
Hans-Stefan Hofmann, Prof. Dr. med.
Role: primary
Other Identifiers
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23-079
Identifier Type: -
Identifier Source: org_study_id
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