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To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostomy 1 | Other | 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2 |
|
| Ostomy 2 | Other | 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1 |
|
| Ostomy 3 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product |
|
| Ostomy 4 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product |
|
| Ostomy 5 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostomy accessory | Device | Wearing each of the devices for 10 days each |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leakage & Wear Time | Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Evaluation and comparison of the safety of three ostomy accessory products | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Peters | ConvaTec Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Nurse Consultants | Tucson | Arizona | 85742 | United States | ||
| ET Nursing Services |
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| Ostomy 6 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1 |
|
| Jacksonville |
| Florida |
| 32257 |
| United States |
| Image Specialties | Saint Joseph | Missouri | 64506 | United States |
| ID MED Inc. | Columbus | Ohio | 43222 | United States |