PMCF Study of the CE-marked Drainova® ArgentiC Catheter

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436807
• Other study ID #: 23-079
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: ewimed GmbH
• Contact: Natasa Mitrovic, MSc
• Phone: +49 7471 9849 9529
• Email: natasa.mitrovic[@]lsmedcap.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: August 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ewimed GmbH	LS medcap GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Catheter patency	Occurrence of catheter blockage, occlusion or displacement	Discharge (1-7 days post-implantation)
Primary	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
Primary	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	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