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

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).