Feasibility of a Newly Developed Ostomy Prototype (NCT07146035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility of a Newly Developed Ostomy Prototype
Denmark10 participantsStarted 2025-08-25
Plain-language summary
Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Has given written informed consent Is at least 18 years old Has full legal capacity Is able (assessed by the investigator) and willing to adhere to study procedures during study duration.
Has had an ileostomy for at least 30 days. Has been self-managing their own ostomy product for at least 14 days. Has experienced leakage under the baseplate at least 3 times within the past 2 weeks.
Is able to fit one of the two test product sizes (Ø50mm or Ø60mm). Uses a flat baseplate Is willing to change their baseplate daily Has intact peristomal skin (assessed by the investigator) Is able to use a smartphone with camera
Exclusion Criteria:
Is participating in any other clinical investigation during this investigation Has previously participated or completed this investigation Has a known hypersensitivity towards the prototype used in the investigation Is pregnant Is breast feeding Has more than one ostomy synchronously Has ongoing non-healed abdominal wounds Has planned MR scans during the 24-hour test recording
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.
What they're measuring
1
To test the system performance of the prototype.
Timeframe: 3 weeks from enrollment to end of treatment