Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device

Overview

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.

Full Title of Study: “A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device in Subjects With a Stoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 15, 2020

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 Investigator/study 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.

Clinical Trial Outcome Measures

Primary Measures

  • Median wear time
    • Time Frame: 2-3 weeks
    • of 8 baseplate changes

Participating in This Clinical Trial

Inclusion Criteria

1. Have a colostomy, ileostomy, urostomy, loop stoma, or two stomas placed closely together 2. Have given written informed consent (the legal authorized representative of the subject) 3. Group 1 subjects should use a competitor device Exclusion Criteria:

1) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (as-sessed by the investigator)

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 4 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Coloplast A/S
  • Collaborator
    • Children’s National
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lone G Pedersen, PhD, 49113259, dklgjp@coloplast.com

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