Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma; Colostomy Stoma

Treatments: Device: Test Product A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03770078

CP300

Details and patient eligibility

About

The study investigates the performance of a new adhesive with regard to the skin condition

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have given written informed consent
• Have an ileostomy or a colostomy with liquid* output (as their usual output)
• Be at least 18 years of age and have full legal capacity
• Have had their stoma for at least three months
• Be able to use products with max cut size 45 mm
• Have self-reported problems with leakage** (three times within 14 days)
• Handle the Clinical App, test product and comparator product themselves
• Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
• Minimum change of baseplate at least once every 3rd day
• Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
• Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion criteria

• Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
• Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
• Are breast feeding
• Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.

• Have known hypersensitivity towards any of the products used in the investigation

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Study period

Experimental group

Description:

First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)

Treatment:

Device: Test Product A