Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03784989
Status:
WITHDRAWN
Last Update Posted:
2022-11-17
First Post:
2018-12-20
Brief Title:
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura Mio Kids Device
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura Mio Kids Device in Subjects With a Stoma
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated
The investigational device is SenSura Mio Kids which is a flat ostomy device The device is comprised by a baseplate connected to a bag The coupling between baseplate and bag can be either welded together referred to as a 1-piece 1P system or assembled as separate parts referred to as a 2-piece 2P system
The investigational device is SenSura Mio Kids which is a flat ostomy device The device is comprised by a baseplate connected to a bag The coupling between baseplate and bag can be either welded together referred to as a 1-piece 1P system or assembled as separate parts referred to as a 2-piece 2P system
Detailed Description:
The purpose of this research is to gather more information about how well the SenSura Mio Kids ostomy device works and how safe it is This device has already been studied and approved to be used in the United States It has a European CE-mark which means it has met European health and safety requirements SenSura Mio Kids is a flat ostomy device that is made to be used for kids from 6 months up to 4 years of age
The reason for this study is to find out how well the new SenSura Mio Kids device works compared to the standard of care device We can learn about this by asking people who have used it about how well it worked and how comfortable it was
The Investigatorstudy nurse will decide whether the subject would benefit from switching to SenSura Mio Kids and if so the subject will be invited to take part in the study The study design is observational That means that the ostomy device and the skin around the stoma will be observed while receiving the stoma care they normally would This study design will help the researchers see how well the device works when it is used in the usual way and makes it easier for the people who are participating in the study
The reason for this study is to find out how well the new SenSura Mio Kids device works compared to the standard of care device We can learn about this by asking people who have used it about how well it worked and how comfortable it was
The Investigatorstudy nurse will decide whether the subject would benefit from switching to SenSura Mio Kids and if so the subject will be invited to take part in the study The study design is observational That means that the ostomy device and the skin around the stoma will be observed while receiving the stoma care they normally would This study design will help the researchers see how well the device works when it is used in the usual way and makes it easier for the people who are participating in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None