Ostomy384 PRO PanelNCT07589907
CP384 - Ostomy Care (OC) PRO Panel Plan
An observational study of Ostomy and Ileostomy - Stoma, run by Coloplast A/S.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy, Ileostomy - Stoma, Urostomy
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cannot have a scheduled stoma reversal surgery
- Cannot have more than one stoma
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD contact
About this study
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.
- Conditions
- Ostomy, Ileostomy - Stoma, Urostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Other: No Intervention: Observational Cohort | There is only one observational cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
The number of leakage events
Frequency and consequences of leakages and Peristomal Skin Complications (PSC).
Measured: 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".
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OstomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Ann-Sophie Luel-Brockdorff, PhD, Study director, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589907
- Sponsor's protocol ID
- CP384
- Acronym
- 384 PRO Panel
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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) . : . .
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CP384 - Ostomy Care (OC) PRO Panel Plan
- ClinicalTrials.gov ID
- NCT07589907
- Acronym / sponsor ID
- 384 PRO Panel / CP384
- Conditions
- Ostomy, Ileostomy - Stoma, Urostomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other: No Intervention: Observational Cohort | – | –There is only one observational cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cannot have a scheduled stoma reversal surgery
- Cannot have more than one stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
The number of leakage events
Time frame: 5 years
Frequency and consequences of leakages and Peristomal Skin Complications (PSC).
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- BackgroundFDA, 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD contact
Ann-Sophie Luel-Brockdorff, PhD study director
Coloplast A/S
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy and Ileostomy - Stoma, run by Coloplast A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carri Browne. Clinical Project Manager, BS (6123235772, dkcarr@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of OC products used by subjects. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.