NCT06965140

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 18, 2025

Status Verified

April 1, 2025

Enrollment Period

25 days

First QC Date

April 22, 2025

Last Update Submit

May 14, 2025

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

  • Thickness of the epidermal layer (assessed by OCT)

    Scan of the peristomal skin

    immediately after the OCT scan

Study Arms (1)

OCT scan + skin measurements abdominal and peristomal skin

OTHER

OCT scan + skin measurements abdominal and peristomal skin

Device: flat 1-piece open ostomy device

Interventions

flat 1-piece open ostomy deviceDEVICE

OCT scan and skin measurements of peristomal and abdominal skin

OCT scan + skin measurements abdominal and peristomal skin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of dermatology and venerology

Copenhagen, 2400, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

May 11, 2025

Study Start

April 7, 2025

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

May 18, 2025

Record last verified: 2025-04

Locations

DK(1)