MedTrace Logo

Feasibility of a Newly Developed Ostomy Prototype

NCT07146035 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-28

No results posted yet for this study

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 the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).

Conditions

  • Stoma - Ileostomy

Interventions

DEVICE

CP369 Feasibility of a newly developed ostomy prototype (only one intervention)

The study is an open-label, single-arm, comparative study, investigating the feasibility of the prototype in subjects with ileostomy. The study is comparing the prototype exposed only to sweat (abdominal side) with the prototype exposed to sweat and output (peristomal side). Meaning, subjects are their own control.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT07146035 on ClinicalTrials.gov