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To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Piece Drainable Pouch | Other | This is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Piece Drainable Pouch | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | To assess the condition of the peristomal skin and stoma and number and frequency of adverse events | Study duration will be 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance/Efficacy | To assess ease of use including ease of application and removal, comfort and security along with wear time | The study will be for 10 days |
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Inclusion Criteria
Exclusion Criteria - The following subjects must not be included into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Popavich-Durnal, RN BSN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Nurse Consultant LLC | Tucson | Arizona | 85742 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 12, 2015 | |
| Reset | Nov 10, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 12, 2015 | Nov 10, 2015 |
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