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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stoma Ileostomy

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population in this study are subjects from the age of 6 months (calculated from term age meaning 40 gestational weeks) to 4 years either with a colo-, ileo- or urostomy or a loop stoma, or two stomas placed closely together. Subjects can participate in the PMCF study if they fulfill the in-/exclusion criteria as listed in the tables below. However, the per protocol population only include 30 subjects as needed for the compara-tive performance evaluation (Group 1), and these subjects must fulfill inclusion criteria no. 3 (subjects should use a competitor device).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median wear time	of 8 baseplate changes	2-3 weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Collaborators: IWK Health Centre; Children's National; Driscoll Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): September 8, 2020
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CP281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No