- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517541
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.
Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.
The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.
The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9713
- QPS Netherlands
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Larvik, Norway, 3269
- Helse Nordbyen
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Birmingham, United Kingdom, B15 2SQ
- Synexus Midlands
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Boston, United Kingdom
- Pilgrim Hospital
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Cheltenham, United Kingdom, G1537AN
- Cheltenham General Hospital
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Kettering, United Kingdom, NN168UZ
- Kettering General Hospital
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Lincoln, United Kingdom, LN25QY
- Lincon Country hospital
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Medicine
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Minnesota
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Saint Paul, Minnesota, United States, 55114
- PRISM Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have an ileostomy or colostomy
- Have had their ostomy for at least 3 months
- Must use 1 piece open or closed ostomy products during the test period
- Currently using a 1 piece. flat product
- Must be able to use custom cut product
- Have intact peristomal skin
- Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
- Are evaluated to be suitable for a soft convex product
Exclusion Criteria:
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently or having within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Test period
The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft)
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SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Leakage Under the Baseplate (cm^2)
Time Frame: 14 weeks (2 weeks baseline + 12 weeks intervention)
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The leakage area was measured using photos of used baseplates.
A computer program was used to measure the leakage area.
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14 weeks (2 weeks baseline + 12 weeks intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Camilla F Vibjerg, M.Sc.pharm, Head of Clinical Operations
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP259
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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