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).