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

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.

Study Overview

• Status: Recruiting
• Conditions: Ascites; Pleural Effusion, Malignant; Pleural Effusion; Ascites, Malignant
• Intervention / Treatment: Device: Indwelling 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.

• Study Type: Observational
• Enrollment (Estimated): 162

Contacts and Locations

• Study Contact: Name: Natasa Mitrovic, MSc; Phone Number: +49 7471 9849 9529; Email: natasa.mitrovic@lsmedcap.com
• Study Contact Backup: Name: Heidrun Steinle, Dr; Phone Number: +49 7471 9848 0175; Email: heidrun.steinle@lsmedcap.com

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitätsklinikum Regensburg
    • Contact: Hans-Stefan Hofmann, MD, Prof.
  • Regensburg, Germany, 93049
    • Recruiting
    • Krankenhaus Barmherzige Brüder
    • Contact: Hans-Stefan Hofmann, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent, refractory, malignant and non-malignant effusions in serous body cavities according to the IFU.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascites- and pleural effusion-associated symptom relief	Measured by assessing the VAS score of the patient´s symptoms (e.g. pain) at baseline and discharge (defined by clinical routine).	Discharge (1-7 days post-implantation)
Catheter patency	Occurrence of catheter blockage, occlusion or displacement	Discharge (1-7 days post-implantation)
Implantation success	Must meet the following items: Successful placement at the defined location; Feasibility of initial drainage of fluid (volume in ml)	Immediately after procedure
Incidence of major adverse events, infections and device deficiencies	Frequency of device- and/ or procedure-related major adverse events (MAEs), infections and device deficiencies	Up to three months post-implanatation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of the patients´ quality-of-life vs. baseline	Quality-of-life will be assessed by QoL questionnaire	discharge (1-7 days post-implantation), 30 days, 3 months

Collaborators and Investigators

• Sponsor: ewimed GmbH
• Collaborators: LS medcap GmbH
• Investigators: Study Chair: Heidrun Steinle, Dr, LS medcap GmbH

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Ascites; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: 23-079