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A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One piece closed pouch | Other | One piece closed pouch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One piece closed pouch | Device | A one piece closed pouch for the collection of stool from a colostomy stoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma | 10 days - duration of study period |
| Measure | Description | Time Frame |
|---|---|---|
| Performance/Efficacy | Performance/Efficacy of the pouch to stay in place and collect stool from the stoma. Ease of use, security will be assessed | 10 days duration of study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Popovich-Durnal, RN BSN | Unafilliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Nurse Consultants LLC | Tucson | Arizona | 85742 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 20, 2017 | |
| Reset | Jan 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 20, 2017 | Jan 22, 2018 |
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