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The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coloplast Test Product then Comparator | Experimental | The subject first tests the Coloplast Test Product and then tests the Comparator |
|
| Comparator then Coloplast Test Product | Experimental | The subject first tests the Comparator and then tests the Coloplast Test Product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test Product | Device | A new 2-piece ostomy appliance developed by Coloplast A/S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". | Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good". | 21 +/- 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial Form Support ApS (TFS) | Soeborg | 2860 | Denmark | |||
| Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie |
One subject was a screen failure and was not exposed to any of the test products. This subject was excluded from the safety population, which therefore included 52 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coloplast Test Product Then Comparator | The subject first tests the Coloplast Test Product and then tests the Comparator Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag. |
| FG001 | Comparator Then Coloplast Test Product | The subject first tests the Comparator and then tests the Coloplast Test Product. Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All subjects included in the investigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good". | Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good". | Posted | Number | percentage of subjects answering | 21 +/- 3 days |
|
Adverse events were collected during the study period: 42 days +/- 6 days
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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 | Coloplast Test Product | Answers from subjects testing Coloplast test product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | not related to Comparator product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related adverse events to either Test product or Comparator (adverse event categorised as unlikely related, probably related, possibly related and definitly related are treated as related adverse events). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Coloplast | 0045 49111990 | dkcfv@coloplast.com |
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| Comparator (Hollister) | Device | Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag. |
|
| Berlin |
| 12203 |
| Germany |
| SIEWA Coloplast Homecare | Hamburg | 22045 | Germany |
| QPS Netherlands | Groningen | 9713G12 | Netherlands |
| Sykepleierklinikken A/S, Larvik | Larvik | 3269 | Norway |
| NOT COMPLETED |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 51 |
| 9 |
| 51 |
| EG001 | Comparator | Answers from subjects testing Comparator | 3 | 49 | 17 | 49 |
|
| Compartment syndrome in left lower leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | not related to Comparator product |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment | not related to Comparator product |
|
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