Clinical trial · Interventional
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Controlled Randomized Study With a New Base Plate Versus SenSura Base Plate on Perspiring Skin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Athena | Device | — | UNRESOLVED |
| SenSura | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SenSura Adhesive (device)
- description
- Sensura is a commercially available adhesive, that is designed to collect output from a stoma.
- interventionNames
- Device: SenSura
- type
- EXPERIMENTAL
- label
- Athena adhesive
- description
- Athena = new test adhesive. The Athena baseplate is intended for collecting output from a stoma.
- interventionNames
- Device: Athena
Primary outcomes (1)
- measure
- Visual Inspection of Baseplate Loosening
- timeFrame
- 1 hour
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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, elevated blood pressure, diabetes or any form of cardiovascular disease. * Currently receiving or have within the last 3 weeks received local treatment with steroids (ointment or creme) on back or stomach\* * Group A may not have a stoma * Group B may not use convex base plates \* Radio- and chemotherapy can lead to changes in the skin and intestine. It is known that steroid can lead to fragile skin which can affect application and removal of the adhesive
References
Publications (0)
Data not yet available