Study Stopped
lack of recruitment
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Baby Device in Subjects With a Stoma
1 other identifier
observational
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 24, 2019
CompletedFirst Posted
Study publicly available on registry
April 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2020
CompletedMarch 11, 2025
March 1, 2025
1.7 years
April 24, 2019
March 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Median wear time
3 weeks
Eligibility Criteria
The population in this study are (premature) infants over 30 weeks of gestation up to 6 months of age (calculated from term age meaning 40 GW) either with a colo- or, ileo-, or jejunostomy 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 include minimum 30 subjects from Group 1 or 2 as needed for the comparative performance evaluation.
You may qualify if:
- Have a colostomy, ileostomy (jejunostomy), loop stoma, or two stomas placed closely together
- Have given written informed consent (the legal authorized representative of the subject)
You may not qualify if:
- The subjects are not allowed to participate in case they:
- Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
- Children's National Research Institutecollaborator
- IWK Health Centrecollaborator
- Driscoll Children's Hospitalcollaborator
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2019
First Posted
April 29, 2019
Study Start
January 1, 2019
Primary Completion
September 8, 2020
Study Completion
September 8, 2020
Last Updated
March 11, 2025
Record last verified: 2025-03