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Hospital had initiated a conflicting study, hence the study was terminated.
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The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consure 120 Stool Management System | Device | Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual confirmation that fecal material is diverted into the external collection bag through the device. | Yes or No response to visual observation of stool being collected through the transit sheath and collection bag. | 120 +/- 8 hours |
| Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device. | Yes or No response to visual observation of soiling, leaking or seepage around periphery of device. | 120 +/- 8 hours |
| Number of hours for which the device stays on without change or removal. | Quantitative measure of duration of device use. The cause of the change or removal will be documented. | 120 +/- 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device. | Yes or No response from visual observation of any bleeding on the external periphery of the device. | 120 +/- 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp HealthCare | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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