Trial Outcomes & Findings for Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy (NCT NCT02675634)

Last Updated: 2017-10-16

Results Overview

Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

14 +/- 2 days

Results posted on

2017-10-16

Participant Flow

The subjects were recruited through the Coloplast A/S database and from hospital sites

Participant milestones

Participant milestones
Measure	Test A, Test B, Subjects Own Product The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test A, Subjects Own Product, Test B The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test B, Test A, Subjects Own Product The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test B, Subjects Own Product, Test A The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Subjects Own Product, Test A, Test B The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Subjects Own Product, Test B, Test A The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.
Test Period 1 STARTED	10	8	9	9	10	9
Test Period 1 COMPLETED	10	7	8	8	10	9
Test Period 1 NOT COMPLETED	0	1	1	1	0	0
Test Period 2 STARTED	10	7	8	8	10	9
Test Period 2 COMPLETED	9	7	8	8	10	8
Test Period 2 NOT COMPLETED	1	0	0	0	0	1
Test Period 3 STARTED	9	7	8	8	10	8
Test Period 3 COMPLETED	9	7	8	8	10	8
Test Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test A, Test B, Subjects Own Product The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test A, Subjects Own Product, Test B The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test B, Test A, Subjects Own Product The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Test B, Subjects Own Product, Test A The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.	Subjects Own Product, Test B, Test A The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.
Test Period 1 Adverse Event	0	1	0	1	0
Test Period 1 Device deficiency that did not lead to A	0	0	1	0	0
Test Period 2 Lack of Efficacy	1	0	0	0	0
Test Period 2 Adverse Event	0	0	0	0	1

Baseline Characteristics

One subject did not aswer the gender question therefore this information is missing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Study Population n=55 Participants This consists of all participants who were enrolled in the study
Age, Continuous	69 years STANDARD_DEVIATION 11.2 • n=55 Participants
Sex: Female, Male Female	14 Participants n=54 Participants • One subject did not aswer the gender question therefore this information is missing.
Sex: Female, Male Male	40 Participants n=54 Participants • One subject did not aswer the gender question therefore this information is missing.

PRIMARY outcome

Timeframe: 14 +/- 2 days

Outcome measures

Outcome measures
Measure	Test A n=51 Participants This is the result from all subjects evaluating Test A	Test B n=54 Participants This is the results from all the subjects evaluating Test B	Own Product n=51 Participants this is the result from all the subjects evaluating Own product.
Fit to Body	93 percentage of good or very good	88 percentage of good or very good	57 percentage of good or very good

Adverse Events

Test A

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Test B

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Own Product

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test A n=52 participants at risk This is the result from all subjects evaluating Test A	Test B n=54 participants at risk This is the results from all the subjects evaluating Test B	Own Product n=51 participants at risk this is the result from all the subjects evaluating Own product.
Gastrointestinal disorders Obstibation	1.9% 1/52 • Number of events 1 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.	0.00% 0/54 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.	0.00% 0/51 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.

Other adverse events

Other adverse events
Measure	Test A n=52 participants at risk This is the result from all subjects evaluating Test A	Test B n=54 participants at risk This is the results from all the subjects evaluating Test B	Own Product n=51 participants at risk this is the result from all the subjects evaluating Own product.
Skin and subcutaneous tissue disorders Peristomal skin dermatitis	15.4% 8/52 • Number of events 8 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.	20.4% 11/54 • Number of events 12 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.	7.8% 4/51 • Number of events 5 • Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.

Additional Information

Sara Gosk

Scientific and Regulatory affairs

Phone: +45 49113568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60