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The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
72 subjects will be included. Each subject will attend 3 visits at the clinic/hospital or at the subjects home depending on the final site set-up. Each subject will be enrolled for 14 weeks in total for the entire investigation.
Coloplast will provide SenSura Mio Convex Soft for all subjects via the investigator. Based on the subjects' usual changing pattern, the investigator will provide the subjects with enough products for the whole test period.
The subject will answer questions regarding the tested products by filling out the subject part in the eCRF daily. The subject will answer questions using an electronic device and use the device to take pictures of the peristomal skin and used products at each product change. The Investigator fills out the investigator part of the eCRF at each visit. The subjects must complete the general questions at the end of each test period before their second and third visit at the Clinic/hospital or at home to avoid influence by the investigator.
The use of accessories will be noted in the eCRF. Samples of biological material will not be taken or used in this investigation. Patient files from own physician will not be used for subjects recruited via a Coloplast's database. The investigators may use patient files for subjects recruited via hospital sites/ostomy clinics to identifying relevant subjects and/or to verify baseline information, concomitant medication or adverse events. To be able to fulfil the objectives, the investigation must include both ileostomists and colostomists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test period | Experimental | The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura Mio Convex Soft | Device | SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leakage Under the Baseplate (cm^2) | The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. | 14 weeks (2 weeks baseline + 12 weeks intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camilla F Vibjerg, M.Sc.pharm | Head of Clinical Operations | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States | ||
| Prism research center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Period | The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Period (Own Product) |
|
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| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| QPS Netherlands | Groningen | 9713 | Netherlands |
| Helse Nordbyen | Larvik | 3269 | Norway |
| Synexus Midlands | Birmingham | B15 2SQ | United Kingdom |
| Pilgrim Hospital | Boston | United Kingdom |
| Cheltenham General Hospital | Cheltenham | G1537AN | United Kingdom |
| Kettering General hospital | Kettering | NN168UZ | United Kingdom |
| Lincon Country hospital | Lincoln | LN25QY | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| Test Period (SenSura Mio Convex Soft) |
|
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All subjects who were included in the safety population of the investigation. One subject did not provide baseline data as the subject violated the protocol and terminated the study. Therefore, no baseline data was recorded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Period | The arm consists of a two-week baseline period where subjects apply their own product and a 12 weeks test period where the subjects apply the intervention (SenSura Mio Convex Soft) SenSura Mio Convex Soft: SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leakage Under the Baseplate (cm^2) | The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area. | Posted | Mean | Standard Deviation | cm2 | 14 weeks (2 weeks baseline + 12 weeks intervention) | baseplates | baseplates |
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The adverse events were collected in the study period (14 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Own Product | The mean leakage area measured on the subjects own baseplate | 0 | 74 | 0 | 74 | 17 | 74 |
| EG001 | SenSura Mio Convex Soft | The mean leakage area measured on SenSura Mio Convex Soft baseplates | 0 | 71 | 1 | 71 | 25 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment | During a routine visit at the hospital her potassium values were too low so the medical staff decided to keep her overnight and administer potassium by means of an IV drip |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Red, eroded peristomal skin |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zenia M Størling | Scientific and Regulatory affairs | +45 49111869 | dkzenst@coloplast.com |
| Withdrawal by Subject |
|
| One subjects was not suited for the tes |
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