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

NCT03784989 | Withdrawn

• 1 other identifier: CP281
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Median wear time

  of 8 baseplate changes

  2-3 weeks

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead
• Children's National Research Institute: collaborator
• Driscoll Children's Hospital: collaborator
• IWK Health Centre: collaborator

Study Sites (1)

Driscoll Childrens Hospital

Corpus Christi, Texas, 78411, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: April 15, 2019
• Primary Completion: September 8, 2020
• Study Completion: September 8, 2020
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

US (1)