Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03929978 |
| Other study ID # |
CP280 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2019 |
| Est. completion date |
September 8, 2020 |
Study information
| Verified date |
November 2022 |
| Source |
Coloplast A/S |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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:
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: 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.
