NCT02517541

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ileostomy - Stoma
• Colostomy

Interventions

Type	Name	Description
DEVICE	SenSura Mio Convex Soft	SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-08-07
• Last updated: 2022-11-16
• Results posted: 2018-09-06

Locations

9 sites across 4 countries: United States, Netherlands, Norway, United Kingdom