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The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1; First Coloplast Test product 1 | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 1 and secondly test either:
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| Treatment seqence 2; First Coloplast Test product 2. | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast Test product 2 and secondly test either:
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| Treatment sequence 3, First Coloplast SenSura | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects are first allocated to test Coloplast SenSura and secondly test either:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test Product 1 | Device | Coloplast Test product 1 is a newly developed 1-piece ostomy appliance |
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| Measure | Description | Time Frame |
|---|---|---|
| Leakage | The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. | 14 +- 1 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 |
|---|---|---|---|---|---|---|
| Holtedam 3 | Humlebæk | 3050 | Denmark | |||
| QPS Nederlands |
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The subjects were recruited through the Coloplast database and hospital sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | SenSura/Test 1/Test 2 | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| FG001 | SenSura/Test 2/Test 1 | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| FG002 | Test 1/SenSura/Test 2 | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| FG003 | Test 1/Test 2/SenSura | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| FG004 | Test 2/SenSura/Test 1 | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| FG005 | Test 2/Test 1/SenSura | The subjects in this group test the following in the order described below:
The products are single use products which in average are removed and re-applyed every1-2nd day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 (2 Weeks) |
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| Test Period 2 (2 Weeks) |
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| Test Period 3 (2 Weeks) |
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Of the183 randomised subjects 4 subjects were not exposed to a product and were only included in the safety population (N =179). Of the 179 subjects 5 subjects were not included in the ITT population as no endpoint data was recorded for these subjects. The ITT population consisted of 174 subjects. Baseline data is only summerized for ITT subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects |
| 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 | Leakage | The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. | Posted | Number | percentage of baseplates | 14 +- 1 days | baseplates | baseplates |
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Adverse event data was collected during each test period 2 weeks +- 1 day
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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 1 | Subjects testing Coloplast Test 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Coloplast | +45 4911 1395 | dkbir@coloplast.com |
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| Coloplast Test Product 2 | Device | Coloplast Test product 2 is a newly developed 1-piece ostomy appliance |
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| Coloplast SenSura | Device | SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S. |
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| Groningen |
| 9713 |
| Netherlands |
| Sykepleierklinikken | Larvik | 3269 | Norway |
| Synexus Limited | Chorley | Lancashire | PR71NY | United Kingdom |
| Protocol Violation |
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| Adverse Event |
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| Withdrawal by Subject |
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| subject did not want to wait for cut bag |
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| screen failure |
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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 |
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| Sex: Female, Male | Count of Participants | Participants |
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Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura |
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| 3 |
| 162 |
| 38 |
| 162 |
| EG001 | Test 2 | Subjects testing Coloplast Test 2 | 2 | 163 | 24 | 163 |
| EG002 | SenSura | Subjects testing SenSura | 5 | 163 | 27 | 163 |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment | Not related to device |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to device |
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| Superficial Abscess - surcically drained | Infections and infestations | Non-systematic Assessment | Unlikely related to device |
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| Dehydration after abdominal infection | Infections and infestations | Non-systematic Assessment | Not related to device |
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| Nephrolitiasis | Renal and urinary disorders | Non-systematic Assessment | Not related to device |
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| AC Ileus | Gastrointestinal disorders | Non-systematic Assessment | Not related to device |
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| Blocked Stoma | Gastrointestinal disorders | Non-systematic Assessment | Not related to device |
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| Lung Cancer Complication | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to device |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment | Unlikely related to device |
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| Lacerations left hand requiring suturs following dog attack | Social circumstances | Non-systematic Assessment | Not related to device |
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