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NCT Number: NCT07589907

CP384 - Ostomy Care (OC) PRO Panel Plan

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).

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Key information

Conditions

Ostomy Ileostomy - Stoma Urostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of OC products used by subjects.

    Time frame: 5 years

    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.

  2. The number of leakage events

    Time frame: 5 years

    Frequency and consequences of leakages and Peristomal Skin Complications (PSC).

  3. The Mental well-being index (WHO-5)

    Time frame: 5 years

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD

CONTACT

[email protected]

+45 49112078

Carri Browne. Clinical Project Manager, BS

CONTACT

[email protected]

6123235772

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Acronym: 384 PRO Panel

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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