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The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteemâ„¢ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIPER | Device | Comparison of ostomy systems | ||
| Esteemâ„¢ Cut to Fit One Piece Closed End Pouch | Device | Comparison of ostomy systems |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Related Events | All adverse events (AE's) related to the use of the device | 17 hours |
| Efficacy: Device Fall-Offs | The number and percentage of subjects with study device fall-off during the study | 17 hours |
| Efficacy: Device Fall-Offs | The total number of study device fall-offs during the course of the study | 17 hours |
| Safety: Skin Reactions | 17 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesive | Initial tack of the adhesive (during first hour of wear) | 1 hour |
| Ease of Removal | Ease of removal of the adhesive wafer from the skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, PhD | ConvaTec Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Susan Bell, RN, MSN, CWOCN | Jobstown | New Jersey | 08041 | United States |
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| 17 hours |
| Security | Perceived security of the study pouch during wear | 17 hours |