Status:
NOT_YET_RECRUITING
Feasibility of a Newly Developed Ostomy Prototype
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma - Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07146035
Start Date
August 25 2025
End Date
September 30 2025
Last Update
August 28 2025
Active Locations (1)
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1
Coloplast, UserLab
Humlebæk, Denmark