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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Other: No Intervention: Observational Cohort | There is only one observational cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carri Browne. Clinical Project Manager, BS | Contact | 6123235772 | dkcarr@coloplast.com | |
| Ann-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD | Contact | +45 49112078 | dkasib@coloplast.com |
| Name | Affiliation | Role |
|---|---|---|
| Ann-Sophie Luel-Brockdorff, PhD | Coloplast A/S | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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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