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Clinical Trials/NCT07589907
NCT07589907Not yet recruitingNot Applicable

CP384 - Ostomy Care (OC) PRO Panel Plan

Coloplast A/S0 sites1,000 target enrollmentStarted: June 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
1,000

Study Overview

Brief Summary

The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).

Detailed Description

The objective of the registry is to allow for insights into the needs of people with intimate healthcare needs from the perspective and experience of the user of ostomy products. The registry will provide valuable information from the participants' perspective on several issues including but not limited to product use and satisfaction, frequency of leakage and peristomal skin complications (PSC), healthcare use, and Quality-of-Life (QoL) both general and stoma related. The registry will allow for a more user-centric approach, when listening and responding to the needs and challenges of people living with a stoma.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years of age or above
  • full legal capacity
  • willing and able to complete online questionnaires
  • have either an ileostomy, a colostomy, or a urostomy

Exclusion Criteria

  • Cannot have a scheduled stoma reversal surgery
  • Cannot have more than one stoma

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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