Status:
WITHDRAWN
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
Lead Sponsor:
Coloplast A/S
Collaborating Sponsors:
Children's National Research Institute
Driscoll Children's Hospital
Conditions:
Stoma Ileostomy
Eligibility:
All Genders
6-4 years
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 devi...
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...
Eligibility Criteria
Inclusion
- Have a colostomy, ileostomy, urostomy, loop stoma, or two stomas placed closely together
- Have given written informed consent (the legal authorized representative of the subject)
- Group 1 subjects should use a competitor device
Exclusion
- 1\) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (as-sessed by the investigator)
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03784989
Start Date
April 15 2019
End Date
September 8 2020
Last Update
November 17 2022
Active Locations (1)
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1
Driscoll Childrens Hospital
Corpus Christi, Texas, United States, 78411