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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06436807
Other study ID # 23-079
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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