Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy (CP257)

Coloplast

Status: Completed

Conditions: Stoma Ileostomy

Treatments: Device: SenSura; Device: SenSura test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02887144

Coloplast - CP257

Details and patient eligibility

About

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.

Full description

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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 2 patient groups

SenSura test product 1pc

Experimental group

Description:

Subjects randomized to treatment sequence 1test: 1. SenSura test product 2. SenSura

Treatment:

Device: SenSura

Device: SenSura test product

SenSura 1pc

Experimental group

Description:

Subjects randomized to treatment sequence 2 test: 1. SenSura 2. SunSura test product

Treatment:

Device: SenSura

Device: SenSura test product