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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-04-16

Brief Summary

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

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Detailed Description

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Conditions

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Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Silent arm

The participants test the new Coloplast ostomy device use the product as they usually would.

Group Type EXPERIMENTAL

Coloplast ostomy device

Intervention Type DEVICE

the test product is a newly developed Coloplast ostomy device

Active arm

The participants test the tnew Coloplast ostomy device and are guided by the measuring device

Group Type EXPERIMENTAL

Coloplast ostomy device

Intervention Type DEVICE

the test product is a newly developed Coloplast ostomy device

Interventions

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Coloplast ostomy device

the test product is a newly developed Coloplast ostomy device

Intervention Type DEVICE

Eligibility Criteria

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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
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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No