Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436807
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-15
Brief Title:
PMCF Study of the CE-marked Drainova ArgentiC Catheter
Sponsor:
ewimed GmbH
Organization:
ewimed GmbH
Study Overview
Official Title:
Post-Market Clinical Follow-up Study to Assess the Safety Performance and Clinical Benefit of the CE-marked Drainova ArgentiC Catheter
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 9342EEC thus being considered a legacy device under the Medical Device Regulation EU 2017745 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None