Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

Assessment of the Performance of a New Ostomy Device in Sub-jects Having an Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439241
• Other study ID #: CP278
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: April 16, 2018

Study information

• Verified date: June 2018
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose was to investigate the performance of a new ostomy device measured with a measuring device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority

2. Be at least 18 years of age and have full legal capacity

3. Have had their ileostomy for at least 3 months

4. Can use a product with max cut size 45 mm

5. Self-reported problems with leakage (3 x within 14 days)

6. Be willing and suitable (determined by the investigator representative) to use the test product without using a paste/mouldable ring during the test period

7. Must be able to use custom cut product

8. Minimum change of product every third day

9. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy is allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)

2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.

3. Are pregnant or breastfeeding

4. 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 (CP278) protocol.

5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)

6. Have known hypersensitivity towards any of the products used in the investigation

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Coloplast ostomy device
the test product is a newly developed Coloplast ostomy device

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wear time (hours)	Wear time is recorded at each baseplate change	14 days