Investigation of a New Stoma Product for People With a Stoma
NCT ID: NCT04101318
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2020-01-22
2020-07-17
Brief Summary
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Detailed Description
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The participant will first be included in an information and inclusion visit (V0) and after signing all consent forms will complete three test visits (V1, V2, and V3). Each participant will be enrolled for 2 × 42±3 days in total for the entire investigation, thus for a maximum of 90 days.
The study is a randomised, controlled, open-label, comparative, cross-over, multicentre investigation with two test periods. The study was conducted in four different countries (UK, Germany, Italy, and Norway) with a total of six sites participating.
The study is now complete.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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The non-Conformité Européene marked product, a Conformité Européene marked product
Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days.
Non-Conformité Européene marked product
New Baseplate is not named at this point
Conformité Européene marked competitor products
The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.
A Conformité Européene marked product, then the non-Conformité Européene marked product
Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.
Non-Conformité Européene marked product
New Baseplate is not named at this point
Conformité Européene marked competitor products
The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.
Interventions
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Non-Conformité Européene marked product
New Baseplate is not named at this point
Conformité Européene marked competitor products
The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.
Eligibility Criteria
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Inclusion Criteria
2. Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
3. Currently using a flat product
4. Be at least 18 years of age and have full legal capacity
5. Have had their stoma for at least three months (90 days)
6. Can use a product with a max cut size of 40 mm
7. Has experienced leakage\* under the baseplate at least three times within the last 14 days. \*leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
8. Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below
1. Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days
2. Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days
3. Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area
9. Is able to handle the electronic diary (questionnaire/ photo) themselves.
10. Is able to handle (apply, remove, cut etc.) the product themselves
11. Is willing to not use barrier film or barrier cream during the investigation
12. Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation.
13. Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days.
Exclusion Criteria
\- low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
2. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
* Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed.
* Other systemic steroid treatment (e.g. injection, or tablet) are not allowed.
3. Is breastfeeding
4. Is pregnant (based on pregnancy test -urine)
5. Has known hypersensitivity towards any of the products used in the investigation
\-
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Nazarena Mazzarro, MD
Role: STUDY_DIRECTOR
Coloplast A/S
Locations
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Ragene Saetre
Larvik, , Norway
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP288
Identifier Type: -
Identifier Source: org_study_id
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