MedTrace Logo

Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma

NCT03929978 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-03-11

No results posted yet for this study

Summary

The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.

The objective is to evaluate the SenSura® Mio Baby device performance and safety.

Conditions

  • Stoma Ileostomy

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER

  • IWK Health Centre

    collaborator OTHER

  • Driscoll Children's Hospital

    collaborator OTHER

  • Coloplast A/S

    lead INDUSTRY

Eligibility

Min Age
1 Week
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-09-08
Completion
2020-09-08

More Related Trials

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 NCT03929978 on ClinicalTrials.gov