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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517541
• Other study ID #: CP259
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colostomy
• Ileostomy - Stoma

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)