Status:
COMPLETED
CP376 OCT Exploratory Skin Study
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma Ileostomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be en...
Detailed Description
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be e...
Eligibility Criteria
Inclusion
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Has an ileostomy
- Is using a flat 1-piece open ostomy device
- Have had the ileostomy for a year
Exclusion
- Is currently receiving or have within the past two months received radio-and/or chemotherapy
- Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
- Is pregnant or breastfeeding
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06965140
Start Date
April 7 2025
End Date
May 2 2025
Last Update
May 18 2025
Active Locations (1)
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1
Bispebjerg Hospital, Department of dermatology and venerology
Copenhagen, Denmark, 2400