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

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Device: Coloplast ostomy device

• Registration Number: NCT03439241
• Lead Sponsor: Coloplast A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-20
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-16
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active arm	Coloplast ostomy device	The participants test the tnew Coloplast ostomy device and are guided by the measuring device
Silent arm	Coloplast ostomy device	The participants test the new Coloplast ostomy device use the product as they usually would.

Primary Outcome Measures

Name	Time	Method
wear time (hours)	14 days	Wear time is recorded at each baseplate change

Trial Locations

Locations (1)

Coloplast A/S; 🇩🇰 Humlebæk, Denmark