Completed

Evaluation of New 1-piece Ostomy Product Concept for Ileostomy Patients

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Study Aim

This study aims to evaluate the effectiveness of a new 1-piece ostomy product in reducing leakage for ileostomy patients, by measuring the percentage of all baseplates with leakage using a 4-point scale developed by Coloplast A/S.

What is being tested

Test product

+ SenSura

+ Test product

Device
Who is being recruted

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorColoplast A/S
Last updated: September 30, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

This study is all about testing a newly developed 1-piece ostomy product. It's designed specifically for people who have an ileostomy, a surgical procedure that creates an opening in the belly to remove waste from the body. The goal is to check how well a new adhesive works when combined with a soft top film, and see if it offers better supportive care compared to the current SenSura 1-piece product. During the study, participants will be asked to use the new ostomy product and keep track of any leakage. This is measured using a special 4-point scale created by Coloplast A/S. Every time the baseplate is changed, participants will inspect the skin-facing side and choose one of four options: no leakage, starting to leak, leakage, or sudden leakage. This helps researchers understand how well the new product prevents leakage and if it improves the overall experience for people with an ileostomy.

NCT01799239
Principal SponsorColoplast A/S
Last updated: September 30, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate
Accept to test two 1-piece products within the study period
Be able to handle the bags themselves
Be at least 18 years of age and have full legal capacity
Be suitable for participation in the study and for using a standard adhesive, flat base plate
Show More Criteria
10 exclusion criteria prevent from participating
Are pregnant or breastfeeding
Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
Currently using a ostomy belt
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available.

Group II

Active Comparator
The subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Skövde Hospital

Skövde, SwedenOpen Skövde Hospital in Google Maps
CompletedOne Study Center