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This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period.
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitalaTM | Experimental | A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitalaâ„¢ device when used with these moldable products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalaTM | Device | A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitalaâ„¢ device when used with these moldable products. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity. | Safety will be assessed by measuring the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance (Restoration of Continence) | Performance will be assessed through the restoration of continence | 28 Days |
| Performance (Subjective Assessment) | Performance will be assessed subjectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, PhD | ConvaTec Inc. | Study Director |
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| 28 Days |
| Performance (Leakage Rates) | Performance will be assessed through leakage rates | 28 Days |