Stoma IleostomyNCT03929978
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
An observational study of Stoma Ileostomy, run by Coloplast A/S.
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. Read more about this study
- Who is it for?
- Ages 1 week to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Stoma Ileostomy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 8 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 6 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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
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.
Read the detailed 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:
- 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
- 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.
- Conditions
- Stoma Ileostomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Median wear time
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jan 2019
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma IleostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute, IWK Health Centre, Driscoll Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929978
- Sponsor's protocol ID
- CP280
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2019
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03929978
- Acronym / sponsor ID
- CP280
- Conditions
- Stoma Ileostomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute, IWK Health Centre, Driscoll Children's Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median wear time
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stoma Ileostomy, run by Coloplast A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median wear time (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.