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Not yet recruitingNCT07589907384 PRO PanelUpdated May 15, 2026

CP384 - Ostomy Care (OC) PRO Panel Plan

An observational study in Ostomy, Ileostomy - Stoma and Urostomy, sponsored by Coloplast A/S. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Coloplast A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Ostomy
  • Ileostomy - Stoma
  • Urostomy
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In context

Lead sponsor

Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Other: No Intervention: Observational Cohort

    There is only one observational cohort

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

  2. The number of leakage events

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

    Time frame: 5 years

  3. 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".

    Time frame: 5 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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) . : . .
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07589907
Lead sponsor
Coloplast A/S
Collaborators
IQVIA Pty Ltd
Responsible party
Sponsor
First posted
May 15, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 30, 2032 (estimated)
Completion
Oct 31, 2032 (estimated)
Last update
May 15, 2026

Study contacts

Carri Browne. Clinical Project Manager, BS
Contact
dkcarr@coloplast.com
6123235772
Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD
Contact
dkasib@coloplast.com
+45 49112078
Ann-Sophie Luel-Brockdorff, PhD
study director · Coloplast A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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