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The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1, First Coloplast Test product | Experimental | Subjects first allocated to Coloplast Test product will after cross-over test SenSura |
|
| Treatment seqence 2; First SenSura | Experimental | Subjects first allocated to SenSura will after cross-over test Coloplast Test product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast test product | Device | Coloplast test product is a newly developed 2-piece ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preference | The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. | 21+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 |
|---|---|---|---|---|---|---|
| Imelda Hospital Bonheiden | Bonheiden | 2820 | Belgium | |||
| Aabenraa Stomi Ambulatorie, Sygehus Sønderjylland |
130 subjects were randomised, however 3 of these were not exposed to a product and where not included in the safety population. The participant flow below is generated based on the safety population.
The subjects were recruited from Coloplast user data base, from hospital sites and stoma care sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1, First Coloplast Test Product, the SenSur | Subjects first allocated to Coloplast Test product will after cross-over test SenSura Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Test Period 1 (21 +- 1 Days) |
|
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| SenSura | Device | SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S |
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| Aabenraa |
| 6200 |
| Denmark |
| Coloplast A/S | Humlebæk | 3050 | Denmark |
| Stomiambulatoriet, Kolding Sygehus | Kolding | 6000 | Denmark |
| Stomiambulatoriet A5, Odense Hospital | Odense C | 5000 | Denmark |
| Kirurgisk ambulatorium/Stomiambulatoriet OUH | Svendborg | 5700 | Denmark |
| Vejle Sygehus, Stomiambulatoriet B120 | Vejle | 7100 | Denmark |
| QPS Netherlands | Groningen | 9713 GZ | Netherlands |
| Gastrokirurgisk Sekjon, Kirurgisk Klinikk Haugesund Sjukhus | Haugesund | 5504 | Norway |
| Helse Nordbyen | Larvik | 3269 | Norway |
| Länssjukhhuset gävle, Stomimottagningen | Gävle | 801 87 | Sweden |
| Kirug kliniken Centralsjukhuset | Karlstad | 651 85 | Sweden |
| Kirurgens Mottagning | Malmö | 205 02 | Sweden |
| Capio St. Görans Sjukhus AB, kirurgkliniken | Stockholm | 112 45 | Sweden |
| Södersjukhuset | Stockholm | 117 61 | Sweden |
| karolinska Universitetssjukhuset Solna Stomimottagningen | Stockholm | 171 76 | Sweden |
| Stomimottagningen Centrllasarette i Västerås | Västerås | 721 89 | Sweden |
| FG001 |
| Treatment Seqence 2; First SenSura the Coloplast Test Product |
Subjects first allocated to SenSura will after cross-over test Coloplast Test product Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S |
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| NOT COMPLETED |
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| Test Period 2 (21 +- 1 Days) |
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Baseline data are summarized with the subjects included in the ITT population. Two subjects where exposed to a product but did not register any endpoint data. These subjects are only found in the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | baseline data are 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 | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Preference | The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura. | The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data | Posted | Number | percentage of participants | 21+1 days |
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42+/- 3 days
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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 Product | Safety data for subjects exposed to the test product | 4 | 124 | 27 | 124 | ||
| EG001 | SenSura | Safety data for subjects exposed to SenSura | 1 | 120 | 22 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain in chest | Cardiac disorders | Non-systematic Assessment | not related to device |
| |
| rectal bleeding/inflammtion of the intestine | Gastrointestinal disorders | Non-systematic Assessment | unlikely related to device |
| |
| Sclerosing angiomatoid nodlar tranformation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to device |
| |
| A cystic lesion in operation area | Surgical and medical procedures | Non-systematic Assessment | Not related to device |
| |
| COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to device |
| |
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Not related to device |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peristomal skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | The adverse events are related to the device. Related adverse events includes the adverse events in the categories 'unlikely related', possibly related', 'probably related' and 'definitely related'. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Birte P.Jakobsen | Coloplast | +45 4911 1395 | dkbir@coloplast.com |
| completed early by mistake |
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| device deficiency without AE |
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| Other |
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