Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.

Study Overview
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Brief Summary
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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.

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Consure 120 Stool Management System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool. Non-ambulatory, hospitalized patients. History of passage of at least 1 stool in 24 hours. Exclusion Criteria: Patients with suspected or confirmed rectal mucosal impairment or pathology. Patients with have undergone descending colon or rectal surgery within the preceding six months. Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination. Patients suspected to have impacted stool or is suffering from constipation. Patients with confirmed pregnancy or suspected to be pregnant. Patients that have planned MRI examination over the duration of the study. Patients who have suffered recent cardiac arrest within the preceding 3 months. Patients enrolled in another clinical study or clinical trial. Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Consure 120 Stool Management System|Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, consure medical, semi formed stool, stool management system