NCT06436807

PMCF Study of the CE-marked Drainova® ArgentiC Catheter

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: ewimed GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Effusion
• Pleural Effusion, Malignant
• Ascites
• Ascites, Malignant

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-06-26
• Primary completion: 2025-10-14
• Completion: 2026-01-09
• First posted: 2024-05-31
• Last updated: 2026-03-12

Locations

12 sites across 1 country: Germany