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

NCT03784989 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-11-17

No results posted yet for this study

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

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • Driscoll Children's Hospital

    collaborator OTHER

  • IWK Health Centre

    collaborator OTHER

  • Coloplast A/S

    lead INDUSTRY

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-09-08
Completion
2020-09-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784989 on ClinicalTrials.gov