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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517541
Other study ID # CP259
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date March 2016

Study information

Verified date November 2022
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
SenSura Mio Convex Soft
SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast

Locations

Country Name City State
Netherlands QPS Netherlands Groningen
Norway Helse Nordbyen Larvik
United Kingdom Synexus Midlands Birmingham
United Kingdom Pilgrim Hospital Boston
United Kingdom Cheltenham General Hospital Cheltenham
United Kingdom Kettering General hospital Kettering
United Kingdom Lincon Country hospital Lincoln
United States University of Chicago Medicine Chicago Illinois
United States Prism research center Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leakage Under the Baseplate (cm^2) The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. 14 weeks (2 weeks baseline + 12 weeks intervention)
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