PMCF Study of the CE-marked Drainova® ArgentiC Catheter

ewimed GmbH

Status: Enrolling

Conditions: Pleural Effusion, Malignant; Pleural Effusion; Ascites, Malignant; Ascites

Treatments: Device: Indwelling catheter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06436807

23-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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