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

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

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

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast ostomy device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silent arm; The participants test the new Coloplast ostomy device use the product as they usually would.	Device: Coloplast ostomy device; the test product is a newly developed Coloplast ostomy device
Experimental: Active arm; The participants test the tnew Coloplast ostomy device and are guided by the measuring device	Device: Coloplast ostomy device; the test product is a newly developed Coloplast ostomy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wear time (hours)	Wear time is recorded at each baseplate change	14 days

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): April 16, 2018

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CP278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No