An interventional study of flat 1-piece open ostomy device in Stoma Ileostomy, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Other
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 enrolled.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
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 enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OCT scan + skin measurements abdominal and peristomal skin
Device: flat 1-piece open ostomy device
OCT scan and skin measurements of peristomal and abdominal skin
Thickness of the epidermal layer (assessed by OCT)
Scan of the peristomal skin
Time frame: immediately after the OCT scan
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Coloplast A/S