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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03929978
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : September 25, 2019
Children's National
IWK Health Centre
Driscoll Children's Hospital
Information provided by (Responsible Party):
Coloplast A/S

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.

Condition or disease
Stoma Ileostomy

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Baby Device in Subjects With a Stoma
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

Primary Outcome Measures :
  1. Median wear time [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

  • Inclusion criteria and justification hereof:

    1. Have a colostomy, ileostomy (jejunostomy), loop stoma, or two stomas placed closely together
    2. Have given written informed consent (the legal authorized representative of the subject)

Exclusion Criteria:

  • 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)

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Responsible Party: Coloplast A/S Identifier: NCT03929978    
Other Study ID Numbers: CP280
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No