Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02675634
• Collaborator: (none)
• Enrollment: 55
• Locations: 12
• Arms: 6
• Duration (Months): 5
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy; Colostomy	Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test A, Test B, Subjects own product The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test A, Subjects own product, Test B The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test B, Test A, Subjects own product The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Test B, Subjects own product, Test A The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Subjects own product, Test A, Test B The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.
Experimental: Subjects own product, Test B, Test A The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A	Device: Coloplast Test A; Test A is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: Coloplast Test B; Test B is a new 1-piece ostomy appliance developed by Coloplast A/S; Device: 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.

Outcome Measures

Primary Outcome Measures

1. Fit to Body [14 +/- 2 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)

2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.

3. Are pregnant or breastfeeding**

4. Are participating in other interventional clinical investigations or have previously participated in this investigation

5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)

6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)

7. Have a loop ostomy (also called double barrel ostomy)

8. Have known hypersensitivity towards any of the products used in the investigation

• In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Tempe	Arizona	United States	85282
2	Prism research center	Saint Paul	Minnesota	United States	55114
3	Cleveland Clinic	Cleveland	Ohio	United States	44195
4	TFS	Søborg		Denmark	2860
5	QPS Netherlands	Groningen		Netherlands	9713
6	Synexus Midlands	Birmingham		United Kingdom	B15 2SQ
7	Pilgrim Hospital	Boston		United Kingdom
8	Illingworth Research Nurses	Cheshire		United Kingdom	Sk11 6TG
9	Lincon Country hospital	Lincoln		United Kingdom	LN25QY
10	Aintree University Hospital NHS Foundation Trust	Liverpool		United Kingdom	l9 7AL
11	Kettering General hospital	Northamptonshire		United Kingdom	NN168UZ
12	Synexus Hexam	Northumberland		United Kingdom	NE46 1QJ

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Study Chair: Camilla F Vibjerg, Head of Clinical Operation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT02675634
• Other Study ID Numbers: CP266
• First Posted: Feb 5, 2016
• Last Update Posted: Oct 16, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

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

Arm/Group Title	Test A, Test B, Subjects Own Product	Test A, Subjects Own Product, Test B	Test B, Test A, Subjects Own Product	Test B, Subjects Own Product, Test A	Subjects Own Product, Test A, Test B	Subjects Own Product, Test B, Test A
Arm/Group Description	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.	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.	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.	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.	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.	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.
Period Title: Test Period 1
STARTED	10	8	9	9	10	9
COMPLETED	10	7	8	8	10	9
NOT COMPLETED	0	1	1	1	0	0
Period Title: Test Period 1
STARTED	10	7	8	8	10	9
COMPLETED	9	7	8	8	10	8
NOT COMPLETED	1	0	0	0	0	1
Period Title: Test Period 1
STARTED	9	7	8	8	10	8
COMPLETED	9	7	8	8	10	8
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	The Study Population
Arm/Group Description	This consists of all participants who were enrolled in the study
Overall Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (11.2)
Sex: Female, Male (Count of Participants)
Female	14 25.5%
Male	40 72.7%

Outcome Measures

1. Primary Outcome

Title	Fit to Body
Description	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.
Time Frame	14 +/- 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test A	Test B	Own Product
Arm/Group Description	This is the result from all subjects evaluating Test A	This is the results from all the subjects evaluating Test B	this is the result from all the subjects evaluating Own product.
Measure Participants	51	54	51
Number [percentage of good or very good]	93	88	57

Adverse Events

Time Frame	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.
Arm/Group Title	Test A		Test B		Own Product
Arm/Group Description	This is the result from all subjects evaluating Test A		This is the results from all the subjects evaluating Test B		this is the result from all the subjects evaluating Own product.
All Cause Mortality
	Test A		Test B		Own Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test A		Test B		Own Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/52 (1.9%)		0/54 (0%)		0/51 (0%)
Gastrointestinal disorders
Obstibation	1/52 (1.9%)	1	0/54 (0%)	0	0/51 (0%)	0
Other (Not Including Serious) Adverse Events
	Test A		Test B		Own Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/52 (15.4%)		11/54 (20.4%)		4/51 (7.8%)
Skin and subcutaneous tissue disorders
Peristomal skin dermatitis	8/52 (15.4%)	8	11/54 (20.4%)	12	4/51 (7.8%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.