The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to confirm the established safety and performance of the newly marketed SenSura® Mio Baby device in a real-life setting.~The objective is to evaluate wear time of SenSura® Mio Baby device and other secondary endpoints related to performance, and safety of the device.~Primary endpoint:~• Median wear time~Secondary endpoints:~Fulfillment of wear time expectations~Number of unplanned change episodes~Degree of leakage under the barrier~Other areas of leakage~Easiness of removal of barrier with Brava Baby Adhesive Remover~Skin friendliness~Evaluation of adhesive residues on skin after removal~Frequency of refeeding~Access for refeeding~Hygienic refeeding procedure~Frequency of pouch change~Feeling of security~Evaluation of SenSura® Mio Baby compared to Standard of Care (products used in the department) on comparative questions of performance (to be evaluated by nurses)~Preference~Number of adverse events~The study is a Post Market Clinical Follow-up Study, which is a descriptive study to confirm the established safety and performance of new ostomy devices recently device listed at the US market. Group 1 includes a retrospective data collection with the device used before the date of the study start. For Groups 2 and 3, data are not obtained for performance comparison to current ostomy device, but include prospective descriptive evaluations.~Group 1: subjects having a stoma and using a Standard of Care device. These subjects will transfer to a SenSura® Mio Baby pouch~Group 2: subjects who are newly operated. These subjects will be offered SenSura® Mio Baby pouch as their first device~Group 3: subjects receiving medication such as chemotherapeutic treatment. These subjects may be newly operated subjects or already using a device. These subjects will transfer to a SenSura® Mio Baby pouch A total of 30 subjects needs to be enrolled in Group 1 and 2. A total of 6 subjects can be enrolled in Group 3.~For each Investigational site this means:~A total of 10 subjects needs to be enrolled in Group 1 and 2 and additional 2 subjects more can be enrolled in Group 3. However; the recruitment will be competitive between the 3 Investigational sites until the 30 subjects has been enrolled in Groups 1 and 2.~For details about the statistical analyses performed on this group of subjects, please see section 7.~At least 5 of the enrolled subjects should be in the age range from 30 Gestational Weeks (GW) up to 36 GW either from Group 1 or 2, in order to be able to confirm wear time and other performance related claims. In the primary evaluation, the mean median wear time will be compared to a threshold value of 24 hours which is based on a literature assessment of Standard of Care wear time performance.~Population The population in this study are (premature) infants over 30 weeks of gestation up to 6 months of age (cal-culated 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 To be included the subjects must: Justification~To ensure that:~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)~Exclusion criteria The subjects are not allowed to participate in case they: Justification~1) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)~The investigational device is SenSura® Mio Baby. SenSura® Mio Baby is a flat 2-piece (2P) ostomy device with an open bag and a baseplate, intended for premature infants over 30 weeks of gestation up to 6 months of age.~All devices in this study are approved for market release before study initiation.~Investigation approval~The non-interventional Post Market Clinical Follow-up (PMCF) study will be approved by local or central IRB in the US before study initiation.
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.