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

NCT02675634 | Completed Results

• 1 other identifier: CP266
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 12

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.

Conditions

Ileostomy; Colostomy

Outcome Measures

Primary Outcomes (1)

• Fit to Body

  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.

  14 +/- 2 days

Study Arms (6)

Test A, Test B, Subjects own product

EXPERIMENTAL

The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Test A, Subjects own product, Test B

EXPERIMENTAL

The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Test B, Test A, Subjects own product

EXPERIMENTAL

The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Test B, Subjects own product, Test A

EXPERIMENTAL

The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Subjects own product, Test A, Test B

EXPERIMENTAL

The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Subjects own product, Test B, Test A

EXPERIMENTAL

The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A

Device: Coloplast Test A; Device: Coloplast Test B; Device: Subjects own product

Interventions

Coloplast Test A DEVICE

Test A is a new 1-piece ostomy appliance developed by Coloplast A/S

Subjects own product, Test A, Test B; Subjects own product, Test B, Test A; Test A, Subjects own product, Test B; Test A, Test B, Subjects own product; Test B, Subjects own product, Test A; Test B, Test A, Subjects own product

Coloplast Test B DEVICE

Test B is a new 1-piece ostomy appliance developed by Coloplast A/S

Subjects own product, Test A, Test B; Subjects own product, Test B, Test A; Test A, Subjects own product, Test B; Test A, Test B, Subjects own product; Test B, Subjects own product, Test A; Test B, Test A, Subjects own product

Subjects own product DEVICE

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; Subjects own product, Test B, Test A; Test A, Subjects own product, Test B; Test A, Test B, Subjects own product; Test B, Subjects own product, Test A; Test B, Test A, Subjects own product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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)
• 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.
• Are pregnant or breastfeeding\*\*
• Are participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have a loop ostomy (also called double barrel ostomy)
• 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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (12)

Radiant Research

Tempe, Arizona, 85282, United States

Location

Prism research center

Saint Paul, Minnesota, 55114, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

TFS

Søborg, 2860, Denmark

Location

QPS Netherlands

Groningen, 9713, Netherlands

Location

Synexus Midlands

Birmingham, B15 2SQ, United Kingdom

Location

Pilgrim Hospital

Boston, United Kingdom

Location

Illingworth Research Nurses

Cheshire, Sk11 6TG, United Kingdom

Location

Lincon Country hospital

Lincoln, LN25QY, United Kingdom

Location

Aintree University Hospital NHS Foundation Trust

Liverpool, l9 7AL, United Kingdom

Location

Kettering General hospital

Northamptonshire, NN168UZ, United Kingdom

Location

Synexus Hexam

Northumberland, NE46 1QJ, United Kingdom

Location

Results Point of Contact

• Title: Sara Gosk
• Organization: Scientific and Regulatory affairs

dksargo@coloplast.com

+45 49113568

Study Officials

• Camilla F Vibjerg

  Head of Clinical Operation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 16, 2017
• Results First Posted: September 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); NL (1); DK (1); US (3)