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

Ileostomy - Stoma Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colostomy
• Ileostomy - Stoma

• NCT number: NCT02517541
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Completion date: March 2016