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The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | The subjects randomised to Treatment sequence 1 are going to test
The subjects test the three test products in a randomised order: ABS; BSA; SAB |
|
| Treatment sequence 2 | Experimental | The subjects randomised to Treatment sequence 2 are going to test
The subjects test the three test products in a randomised order: CBS; BSC; SCB |
|
| Treatment sequence 3 | Experimental | The subjects randomised to Treatment sequence 3 are going to test
The subjects test the three test products in a randomised order: ACS; CSA; SAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Adhesive baseplate A | Device | Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices:
| one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte Jakobsen, Dr. | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holtedam 3 | Humlebæk | 3050 | Denmark |
65 participants were recruited. However, one participant was a screen failure and was not randomized and did not try any products.
Recruitment was performed primarily via Coloplast own subject database. In Norway recruitment also took place through medical clinics and hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test A/Test B/SenSura | The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura |
| FG001 | Test A/Test C/SenSura | The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura |
| FG002 | Test B/SenSura/Test A | The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A |
| FG003 | Test B/SenSura/Test C | The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B |
| FG004 | Test C/Test B/SenSura | The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura |
| FG005 | Test C/SenSura/Test A | The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A |
| FG006 | SenSura/Test A/Test B | The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B |
| FG007 | SenSura/Test A/Test C | The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C |
| FG008 | SenSura/Test C/Test B | The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 (1 Week) |
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| Test Period 2 (1 Week) |
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| Test Period 3 (1 Week) |
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Baseline data was obtained on the ITT population. Two subjects were not included in the ITT population. One was discovered before randomization (this subject is not found in the Participant flow), the other was randomized before it was seen that the subjects was screen failure and included in the randomized population but not in the ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population |
| 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 degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices:
| The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis. | Posted | Number | percentage of baseplates with no leakage | one week | baseplates | baseplates |
|
The adverse events were collected during the investigation - up to three 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 | Test A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration | Blood and lymphatic system disorders | Non-systematic Assessment | dehydration due to diarre |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peristomal skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Sinvani | Coloplast A/S | +45 49112356 | dkmards@coloplast.com |
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| Coloplast Adhesive baseplate B | Device | Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance |
|
| Coloplast Adhesive baseplate C | Device | Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance |
|
| SenSura 1-Piece | Device | SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura . |
|
| Adverse Event |
|
| 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 |
|
| OG002 | Test C |
| OG003 | SenSura |
|
|
| 1 |
| 42 |
| 18 |
| 42 |
| EG001 | Test B | 1 | 42 | 12 | 42 |
| EG002 | Test C | 0 | 42 | 11 | 42 |
| EG003 | SenSura | 0 | 62 | 13 | 62 |
|
| obstipation due to parastomal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarre | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
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| skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | not related to product |
|
| stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
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| bleeding from rectum | Gastrointestinal disorders | Non-systematic Assessment |
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| otitis left ear | Ear and labyrinth disorders | Non-systematic Assessment |
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| gout | Immune system disorders | Non-systematic Assessment |
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| influenza | Infections and infestations | Non-systematic Assessment |
|
| active colitis ulcerosa in remaining bowl | Gastrointestinal disorders | Non-systematic Assessment |
|
| small blister on peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | not related to product |
|
| gastroenterotitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| skin injury on forehead and nose | Skin and subcutaneous tissue disorders | Non-systematic Assessment | caused by a mountain bike accident |
|
| pertussis | Infections and infestations | Non-systematic Assessment |
|
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