Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Not Applicable

Completed

• Conditions: Stoma Ileostomy
• Interventions: Device: SenSura; Device: SenSura test product

• Registration Number: NCT02887144
• Lead Sponsor: Coloplast A/S

Brief Summary

The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Detailed Description

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Study Timeline

• Study First Submitted: 2015-12-17
• Study Start: 2016-01
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted QC: 2016-08-29
• Last Update Submitted: 2016-08-29
• Study First Posted: 2016-09-02
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the products themselves
4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
5. Have had their ileostomy for at least 3 months
6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
7. Currently using midi or maxi bags
8. Willing to use minimum 1 product every second day (max. 2 days wear time)
9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
10. Must be able to cut products themselves

Exclusion Criteria

1. Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
6. Known hypersensitivity of the product components and/or ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SenSura 1pc	SenSura test product	Subjects randomized to treatment sequence 2 test: 1. SenSura 2. SunSura test product
SenSura test product 1pc	SenSura	Subjects randomized to treatment sequence 1test: 1. SenSura test product 2. SenSura
SenSura test product 1pc	SenSura test product	Subjects randomized to treatment sequence 1test: 1. SenSura test product 2. SenSura
SenSura 1pc	SenSura	Subjects randomized to treatment sequence 2 test: 1. SenSura 2. SunSura test product

Primary Outcome Measures

Name	Time	Method
Degree of leakage	patients will test the products for 4 weeks	Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebaek, Denmark