Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03929978
Status:
WITHDRAWN
Last Update Posted:
2022-11-17
First Post:
2019-04-24
Brief Title:
Performance and Safety Evaluation of the SenSura Mio Baby Device in Subjects With a Stoma
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 ie bleeding andor 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 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 ie bleeding andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None