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Coloplast A/S has developed a new ostomy device in 8 versions.
The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
The secondary objective is to investigate several performance and safety parameters of the various devices.
The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.
Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.
The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.
Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One arm | Experimental | The arm consists of two periods: in period one, products are tested in the order A, B, C, D, and in period two, products are tested in the order A*, B*, C*, D*. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostomy appliance: convex 1-piece drainable | Device | 8 variations of an ostomy devices are tested |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S | One week |
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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 | Denmark | 3050 | Denmark |
The investigation consisted of two periods: in the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts, Test A*-D*, were developed and tested. The test products were not randomised. The test order in first round was Test A - Test D and in second round it was Test A*-Test D*.
The subject were recruited through the Coloplast A/S user database in Denmark.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test A | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test A was a newly developed concept by Coloplast A/S for the first round. |
| FG001 | Test B | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test B was a newly developed concept by Coloplast A/S for the first round. |
| FG002 | Test C | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test C was a newly developed concept by Coloplast A/S for the first round. |
| FG003 | Test D | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test D was a newly developed concept by Coloplast A/S for the first round. |
| FG004 | Test A* | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test A* was a newly developed optimized concept by Coloplast A/S for the second round. |
| FG005 | Test B* | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test B* was a newly developed optimized concept by Coloplast A/S for the second round. |
| FG006 | Test C* | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test C* was a newly developed optimized concept by Coloplast A/S for the second round. |
| FG007 | Test D* | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Therefore the participant flow is divided by the test products and not for each period. Test D* was a newly developed optimized concept by Coloplast A/S for the second round. |
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| Test Period 1; Test A |
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| Test Period; Test D* |
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| ID | Title | Description |
|---|---|---|
| BG000 | Convex Product Users | Subjects who usually use a convex product |
| BG001 | Flat Product Users | Subjects who usually use a flat product |
| 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 |
| 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 degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate. The scale was developed by Coloplast A/S | Posted | Mean | Standard Deviation | units on a scale | One week | baseplates | Participants |
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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 | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test A was a newly developed concept by Coloplast A/S for the first round. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chemotherapy, cancer in lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to the product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perstomal skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Related to the product |
This was an exploratory investigation where the participating subjects had to test 8 different test products. A small number of subjects were analysed from two different populations (convex product/flat product users).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birte Petersen Jakobsen, MD | Coloplast A/S | +45 4911 1990 | dkbir@coloplast.com |
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| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 |
| Test B - Convex Product Users |
The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test B was a newly developed concept by Coloplast A/S for the first round. |
| OG002 | Test C - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test C was a newly developed concept by Coloplast A/S for the first round. |
| OG003 | Test D - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test D was a newly developed concept by Coloplast A/S for the first round. |
| OG004 | Test A* - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test A* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG005 | Test B* - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test B* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG006 | Test C* - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test C* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG007 | Test D* - Convex Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test D* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG008 | Test A - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test A was a newly developed concept by Coloplast A/S for the first round. |
| OG009 | Test B - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test B was a newly developed concept by Coloplast A/S for the first round. |
| OG010 | Test C - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test C was a newly developed concept by Coloplast A/S for the first round. |
| OG011 | Test D - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test D was a newly developed concept by Coloplast A/S for the first round. |
| OG012 | Test A* - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test A* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG013 | Test B* - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test B* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG014 | Test C* - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test C* was a newly developed optimized concept by Coloplast A/S for the second round. |
| OG015 | Test D* - Flat Product Users | The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*. Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products. Test D* was a newly developed optimized concept by Coloplast A/S for the second round. |
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| 0 |
| 26 |
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| 26 |
| EG001 | Test B | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test B was a newly developed concept by Coloplast A/S for the first round. | 0 | 24 | 6 | 24 |
| EG002 | Test C | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test C was a newly developed concept by Coloplast A/S for the first round. | 0 | 24 | 4 | 24 |
| EG003 | Test D | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test D was a newly developed concept by Coloplast A/S for the first round. | 0 | 26 | 3 | 26 |
| EG004 | Test A* | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test A* was a newly developed optimized concept by Coloplast A/S for the second round. | 1 | 28 | 3 | 28 |
| EG005 | Test B* | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test B* was a newly developed optimized concept by Coloplast A/S for the second round. | 0 | 28 | 3 | 28 |
| EG006 | Test C* | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test C* was a newly developed optimized concept by Coloplast A/S for the second round. | 0 | 26 | 1 | 26 |
| EG007 | Test D* | The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*. Test D* was a newly developed optimized concept by Coloplast A/S for the second round. | 0 | 23 | 3 | 23 |
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| Cold or influenza | Infections and infestations | Systematic Assessment | Not related to the product |
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| Headache | General disorders | Systematic Assessment | Not related to the product |
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| Protocol deviation/not defined | Investigations | Systematic Assessment | Related or possibly related to the product |
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| Cancer, therapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to the product |
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| Infection, tooth | Infections and infestations | Systematic Assessment | Not related to the product |
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| Liver values, increased | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to the product |
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