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The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Teast A; then Coloplast Test B | Experimental | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B |
|
| First Coloplast Test A; Then Standard product | Experimental | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B |
|
| First Coloplast Test B; Then Colopast Test A | Experimental | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A |
|
| First Coloplast Test B; Then Standard product |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test A | Device | Coloplast Test A is a newly developed ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group. | 10 (- 2 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte P Jakobsen, MD | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Coloplast Teast A; Then Coloplast Test B | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| FG001 | First Coloplast Test A; Then Standard Product | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| FG002 | First Coloplast Test B; Then Colopast Test A | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| FG003 | First Coloplast Test B; Then Standard Product | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| FG004 | First Standard Product; Then Coloplast Test A | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| FG005 | First Standard Product, Then Coloplast Test B | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance. Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Baseline data is summarized for all subjects |
| 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 | Degree of Leakage | The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group. | Posted | Mean | Standard Deviation | units on a scale | 10 (- 2 days) |
|
Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.
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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 | Test A + Training Test A | Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A. Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin irritation/broken skin/stomal bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Definitely, probably or possibly related to the product. Causality not defined for 2 events with Test B + Training Test B |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD, Medical Director | Coloplast A/S | +45 4911 1395 | dkbir@coloplast.com |
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| Experimental |
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A |
|
| First Standard product; Then Coloplast Test A | Experimental | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B |
|
| First Standard Product, Then Coloplast test B | Experimental | There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile. The test sequence in this arm is: Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A |
|
| Coloplast Test B | Device | Coloplast Test B is a newly developed ostomy appliance. |
|
| Standard product | Device | Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation. |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Colostomy, Training + Test B |
| OG004 | Colostomy, Standard Care (SenSura Mio) |
| OG005 | Colostomy, Standard Care (SenSura) |
| OG006 | Ileostomy, Test A |
| OG007 | Ileostomy, Training + Test A |
| OG008 | Ileostomy, Test B |
| OG009 | Ileostomy, Training + Test B |
| OG010 | Ileostomy, Standard Care (SenSura) |
|
|
| 0 |
| 22 |
| 8 |
| 22 |
| EG001 | Test B + Training Test B | Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B. Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one. | 0 | 22 | 9 | 22 |
| EG002 | Standard Care | Standard care was used only during part one of the study. i.e. for one period only. | 0 | 22 | 3 | 22 |
|
| Cold or influenza | Infections and infestations | Systematic Assessment | Not related to the product |
|
| Planned operation, non-study related | Eye disorders | Systematic Assessment | Not related to the product |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment | Not related to the product |
|
| Diarrhea or constipation | Gastrointestinal disorders | Systematic Assessment | Not related to the product |
|
| Pain, leg | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to the product |
|
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