CP384 - Ostomy Care (OC) PRO Panel Plan
384 PRO Panel
1 other identifier
observational
1,000
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2032
Study Completion
Last participant's last visit for all outcomes
October 31, 2032
May 15, 2026
May 1, 2026
6.3 years
May 11, 2026
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of OC products used by subjects.
Characterization of a cohort of ostomy care (OC) users at point-of-entry to the registry including e.g., but not limited to OC product consumption, user-patterns, and use of supporting products.
5 years
The number of leakage events
Frequency and consequences of leakages and Peristomal Skin Complications (PSC).
5 years
The Mental well-being index (WHO-5)
Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".
5 years
Study Arms (1)
Other: No Intervention: Observational Cohort
There is only one observational cohort
Eligibility Criteria
Ostomy users will be included in this registry. The registry will be conducted across seven countries: United Kingdom, United States, Denmark, France, Italy, Sweden, and Germany, enrolling a minimum of 1,000 OC users.
You may qualify if:
- years of age or above
- full legal capacity
- willing and able to complete online questionnaires
- have either an ileostomy, a colostomy, or a urostomy
You may not qualify if:
- Cannot have a scheduled stoma reversal surgery
- Cannot have more than one stoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
- IQVIA Pty Ltdcollaborator
Related Publications (1)
FDA, Center for Devices and Radiological Health: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (subsection IB, pages 50-55), March 2021, Link: https://www.fda.gov/media/146258/download) . : . .
BACKGROUND
Study Officials
- STUDY DIRECTOR
Ann-Sophie Luel-Brockdorff, PhD
Coloplast A/S
Central Study Contacts
Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 15, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
September 30, 2032
Study Completion (Estimated)
October 31, 2032
Last Updated
May 15, 2026
Record last verified: 2026-05