A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

Not Applicable

Completed

Conditions: Ileostomy - Stoma
Colostomy

Interventions: Device: SenSura Mio Convex Soft

Registration Number: NCT02517541

Lead Sponsor: Coloplast A/S

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test period	SenSura Mio Convex Soft	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)

Primary Outcome Measures

Name	Time	Method
Leakage Under the Baseplate (cm^2)	14 weeks (2 weeks baseline + 12 weeks intervention)	The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (9): University of Chicago Medicine
🇺🇸
Chicago, Illinois, United States
Prism research center
🇺🇸
Saint Paul, Minnesota, United States
Synexus Midlands
🇬🇧
Birmingham, United Kingdom
Pilgrim Hospital
🇬🇧
Boston, United Kingdom
QPS Netherlands
🇳🇱
Groningen, Netherlands
Helse Nordbyen
🇳🇴
Larvik, Norway
Cheltenham General Hospital
🇬🇧
Cheltenham, United Kingdom
Kettering General hospital
🇬🇧
Kettering, United Kingdom
Lincon Country hospital
🇬🇧
Lincoln, United Kingdom