Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin (NCT01245413) | Clinical Trial Compass
CompletedNot Applicable
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Denmark32 participantsStarted 2010-11
Plain-language summary
Aim
The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
The present investigation aims at testing how well the new Athena base plate adhere to perspiring skin both with and without mechanical exposure (cycling) since the ability to adhere under normal daily activity is an important quality for Coloplast products.
Success criteria:
The investigation is an explorative investigation where the adherence of Athena on perspiring skin is evaluated. Due to the explorative nature of the study it has not been possible to define specific success criteria up front. However, the adherence qualities of Athena may not be significantly reduced compared to SenSura.
Design:
Two groups of men, one group with a colostomy and one group without a colostomy, are included. The men should be cardiovascular fit, be able to cycle for 1 hour at moderate intensity and with Athena and SenSura base plates applied on the back and stomach. The adhesion of the base plates are tested before and after the physical activities.
Population:
The population consists of two groups. Group A: Men in the age of 50-70 without a stoma who have volunteered. Group B: Men with a colostomy who have volunteered. Both groups should be cardiovascular fit (cardio investigated), and be willing to cycle for 1 hour at moderate intensity on an exercise bike.
The Athena test products are non-CE marked, non-sterile, 1-piece ostomy products with a flat custom cut base plate, a closed bag size midi or maxi with the intended use of collecting faeces from the colostomy. The comparator product is a Coloplast SenSura, 1-piece ostomy product with a closed bag. SenSura is CE-marked and launched on the market.
Who can participate
Age range
50 Years – 70 Years
Sex
MALE
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Inclusion Criteria:
* Group A: Men without a stoma in the age of 50-70 years Group B: Men with a stoma
Inclusion criteria:
To be included in the investigation, the subjects in Group A must comply with the following selection criteria:
* Have signed informed consent and letter of attorney
* Be a man in the age of 50-70 years
* Is capable of understanding the experiment
* Have a BMI (body mass index) between 20-30 kg/m2
* Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
* Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
To be included in the investigation, the subjects in Group B must comply with the following selection criteria:
* Have signed informed consent and letter of attorney
* Be a man of at least 18 years of age
* Have a colostomy with a max width of 45 mm and have had the colostomy for at least 3 months
* Is capable of understanding the experiment
* Have a BMI between 20-30 kg/m2
* Is willing to test the adhesives from the two Coloplast products, Athena and SenSura
* Is evaluated as suitable for inclusion according to cardiovascular test and fitness test performed at the screening
Exclusion Criteria:
* Subjects who comply with the following criteria must be excluded from the investigation:
* Have dermatological problems
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Have elevated cholesterol levels, elevat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.