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

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770078
• Other study ID #: CP300
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: September 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma

Intervention

Device:
• Test Product A
The test product is a newly developed ostomy product

Locations

Country	Name	City	State
Denmark	CCBR Aalborg	Aalborg
Denmark	Coloplast	Humlebæk
Denmark	CCBR Vejle	Vejle
Sweden	KTA Prim Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trans Epidermal Water Loss	Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage	Four weeks