Clinical trial NCT02517541: A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Official title: A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Colostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leakage Under the Baseplate (cm^2)
timeFrame: 14 weeks (2 weeks baseline + 12 weeks intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Saint Paul
country: United States
facility: Prism research center
state: Minnesota
city: Groningen
country: Netherlands
facility: QPS Netherlands
city: Larvik
country: Norway
facility: Helse Nordbyen
city: Birmingham
country: United Kingdom
facility: Synexus Midlands
city: Boston
country: United Kingdom
facility: Pilgrim Hospital
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Kettering
country: United Kingdom
facility: Kettering General hospital
city: Lincoln
country: United Kingdom
facility: Lincon Country hospital
Study officials:
affiliation: Head of Clinical Operations
name: Camilla F Vibjerg, M.Sc.pharm
role: STUDY_CHAIR
References: