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The aim of the investigation was to investigate the performance and safety of a new ostomy product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast test product | Experimental | The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light |
|
| First SenSura Convex Light | Experimental | The subjects test: test period 1: SenSura Convex Light test period 2: Coloplast test product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast test product | Device | The Coloplast test product is a newly developed ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate). | 28 +/- 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Carter | Coloplast A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TFS | Søborg | Denmark | ||||
| Hopital du bocage |
129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Coloplast Test Product; Then SenSura Convex Light | The subjects test: test period 1: Coloplast test product test period 2: SenSura Convex Light . |
| FG001 | First SenSura Convex Light; Then Coloplast Test Product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Test Period 1 |
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| SenSura Convex Light | Device | The comparator product is SenSura Convex Light, which is CE-marked and commercially available. |
|
|
| Dijon |
| 21079 |
| France |
| Hopital Robert Boulin | Libourne | 33505 | France |
| Hopital Claude Huriez | Lille | 59037 | France |
| Hopital Nord | Marseille | 13015 | France |
| Hopital Cochin | Paris | 75014 | France |
| Hopital Tenon | Paris | 75020 | France |
| Hopital de Haut Levêque | Pessac | 33604 | France |
| CHRU La Milétrie | Poitiers | 86021 | France |
| BB medica medizinisches | Aachen | Germany |
| Sanitätshause reinhold hilscher e.K. | Augsburg | Germany |
| Patientenberatung Strack e.K. | Bad Staffelstein | Germany |
| Pro-samed Santitätshaus | Berlin | Germany |
| SIEWA coloplast Homecare | Burgdorf, Hanover | Germany |
| SIEWA Coloplast Homecare | Freising | Germany |
| SIEWA Coloplast homecare | Leinfelden-Echterdingen | Germany |
| Schürmaier GmbH &Co | Leipzig | Germany |
| Sanitätshaus Fürst GmbH | Passau | Germany |
| SIEWA Coloplast Homecare | Saulgrub | Germany |
| Sanitäts- und gesundheitshaus Carqueville GmbH | Töppeln | Germany |
| Alippi GmbH | Zwickau | Germany |
| Sykpleierklinikken | Larvik | Norway |
| Pilgrim Hospital | Boston | United Kingdom |
| Addenbrookes | Cambridge | CB20QQ | United Kingdom |
| Cheltenham General Hospital | Gloucestershire | GL53/AI | United Kingdom |
| Lincon Country hospital | Lincoln | LN25QY | United Kingdom |
| Charing Cross Hospital | London | W68RF | United Kingdom |
| Kettering General hospital | Northamptonshire | NN168UZ | United Kingdom |
| west Suffolk Hospital | Suffolk | IP332QZ | United Kingdom |
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
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| Test Period 2 |
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Only subjects in the intention to treat population are included in the baseline population. These were the only subjects who tested the products.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | The investigation is a cross-over investigation therefore the baseline data is given for the 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 | Standard Deviation | years |
| ||||||||||||||||||||||
| Gender | one gender registration was missing | Number | participants |
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| 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 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate). | The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section. | Posted | Mean | Standard Deviation | units on a scale | 28 +/- 3 days | 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 | Coloplast Test Product | Adverse events reported by subjects testing Coloplast test product | 6 | 125 | 28 | 125 | ||
| EG001 | SenSura Convex Light | Adverse events reported by subjects testing SenSura Convex Light | 3 | 120 | 14 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment | unlikely related to the device |
| |
| acute abdominal pain | Gastrointestinal disorders | Systematic Assessment | unlikely related to the device |
| |
| gastrientitis | Infections and infestations | Systematic Assessment | not related to product |
| |
| stoma operation (revision of stome) | Gastrointestinal disorders | Systematic Assessment | not related to product |
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| obstruction of stoma | Gastrointestinal disorders | Systematic Assessment | not related to product |
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| Blocked stoma | Gastrointestinal disorders | Systematic Assessment | not related to product |
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| dehydration | Metabolism and nutrition disorders | Systematic Assessment | not related to product |
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| renal failure | Renal and urinary disorders | Systematic Assessment | not related to product |
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| Severe sepsis in contex of intra abdominal infection | Infections and infestations | Systematic Assessment | not related to product |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritations | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Coloplast A/S | +45 49111395 | dkbir@coloplast.com |
| Other |
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