Clinical trial NCT06436807: PMCF Study of the CE-marked Drainova® ArgentiC Catheter
Official title: Post-Market Clinical Follow-up Study to Assess the Safety, Performance, and Clinical Benefit of the CE-marked Drainova® ArgentiC Catheter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion
Pleural Effusion, Malignant
Ascites
Ascites, Malignant
Lead sponsor: ewimed GmbH
Sponsor class: INDUSTRY
Collaborators: name: LS medcap GmbH
First posted: 2024-05-31
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ascites- and pleural effusion-associated symptom relief
timeFrame: Discharge (1-7 days post-implantation)
measure: Catheter patency
timeFrame: Discharge (1-7 days post-implantation)
measure: Implantation success
timeFrame: Immediately after procedure
measure: Incidence of major adverse events, infections and device deficiencies
timeFrame: Up to three months post-implanatation
Secondary outcomes:
measure: Improvement of the patients´ quality-of-life vs. baseline
timeFrame: discharge (1-7 days post-implantation), 30 days, 3 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH MVZ Flemmingstraße
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Münster
country: Germany
facility: Clemenshospital
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
Study officials:
affiliation: LS medcap GmbH
name: Heidrun Steinle, Dr
role: STUDY_CHAIR
References: