PMCF Study of the CE-marked Drainova® ArgentiC Catheter

NCT06436807 | Completed

• 1 other identifier: 23-079
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 12

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.

Conditions

Pleural Effusion; Ascites; Pleural Effusion, Malignant; Ascites, Malignant

Outcome Measures

Primary Outcomes (4)

• 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: 1. Successful placement at the defined location 2. 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 Outcomes (1)

• Improvement of the patients´ quality-of-life vs. baseline

  discharge (1-7 days post-implantation), 30 days, 3 months

Interventions

Indwelling catheter DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients ≥ 18 years old
• Patients being able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• ewimed GmbH: lead
• LS medcap GmbH: collaborator

Study Sites (12)

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

Location

Klinikum Chemnitz gGmbH MVZ Flemmingstraße

Chemnitz, 09116, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Asklepios Lungenklinik Gauting

Gauting, 82131, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Clemenshospital

Münster, 48153, Germany

Location

Krankenhaus Barmherzige Brüder

Regensburg, 93049, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Pleural Effusion; Pleural Effusion, Malignant; Ascites

Interventions

Catheters, Indwelling

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Heidrun Steinle, Dr

  LS medcap GmbH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 31, 2024
• Study Start: June 26, 2024
• Primary Completion: October 14, 2025
• Study Completion: January 9, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (12)