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CP376 OCT Exploratory Skin Study

NCT06965140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Stoma Ileostomy

Interventions

DEVICE

flat 1-piece open ostomy device

OCT scan and skin measurements of peristomal and abdominal skin

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2025-05-02
Completion
2025-05-02

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965140 on ClinicalTrials.gov