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

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ClinicalTrials.gov Identifier: NCT03929978
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
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

  Show Detailed Description

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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 : May 15, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : June 1, 2020



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


Information from the National Library of Medicine

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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.
Criteria

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
ClinicalTrials.gov Identifier: NCT03929978     History of Changes
Other Study ID Numbers: CP280
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 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